Safety

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-24 (study day 19); relationship: not assessed

Auto-assessed as non-serious (mild). Included in aggregate safety reporting; no expedited report required.

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-11 (study day 469); relationship: not assessed; serious criteria: hospitalization

Participant-reported via Luna chat: "I've had some nausea since yesterday evening". Solicited symptom report logged for the next visit review.

Auto-assessed as non-serious (mild). Included in aggregate safety reporting; no expedited report required.

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-09 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-26 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-21 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 21.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-27 (study day 58.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-11-02 (study day 125.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BUNDLE BRANCH BLOCK LEFT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-10 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HIATUS HERNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HIATUS HERNIA — outcome: RECOVERED/RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-21 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-21 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-03 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PHARYNGOLARYNGEAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-03-21 (study day 80.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-03-31 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS GENERALISED — outcome: RECOVERED/RESOLVED; onset 2014-04-19 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CELLULITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate LOCALISED INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-08 (study day -61.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-02 (study day -5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-26 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-12-26 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-14 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2003; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EYE ALLERGY — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 84.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EYE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EYE SWELLING — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 84.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-22 (study day 97.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINARY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-06-01 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-26 (study day 38.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-22 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-26 (study day 38.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-03 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-16 (study day -4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-05-16 (study day -4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ACTINIC KERATOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-12 (study day 174.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CALCULUS URETHRAL — outcome: RECOVERED/RESOLVED; onset 2013-12-17 (study day 117.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-29 (study day -25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-02; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EPISTAXIS — outcome: RECOVERED/RESOLVED; onset 2014-01-03 (study day 134.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate FLANK PAIN — outcome: RECOVERED/RESOLVED; onset 2013-12-15 (study day 115.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate LOWER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-12 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate LOWER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INCREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INCREASED APPETITE — outcome: RECOVERED/RESOLVED; onset 2013-10-13 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-19 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2002; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-15 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MICTURITION URGENCY — outcome: RECOVERED/RESOLVED; onset 2013-02-15 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-02-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate AGITATION — outcome: RECOVERED/RESOLVED; onset 2013-12-09 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-21 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-04 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-04 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-21 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-05 (study day 137.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2010-06; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2010-06; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate MUSCULAR WEAKNESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate MUSCULAR WEAKNESS — outcome: RECOVERED/RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL MUCOSA BIOPSY — outcome: RECOVERED/RESOLVED; onset 2012-08-03 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PNEUMONIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PNEUMONIA — outcome: RECOVERED/RESOLVED; onset 2012-09-07 (study day 48.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild SECRETION DISCHARGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SECRETION DISCHARGE — outcome: RECOVERED/RESOLVED; onset 2012-08-07 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EYE LASER SURGERY — outcome: RECOVERED/RESOLVED; onset 2013-03-21 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-29 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-16 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-11 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DYSPNOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-11 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INCONTINENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate JOINT DISLOCATION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-21 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN LACERATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-09 (study day 25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe SUDDEN DEATH — outcome: FATAL; onset 2013-01-14 (study day 61.0); relationship: NONE; serious criteria: death, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-20 (study day 10.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-01-20 (study day 10.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HORDEOLUM — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN ODOUR ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-20 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-02-20 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-03-12 (study day 34.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-13 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-02-13 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PAROSMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PAROSMIA — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SALIVARY HYPERSECRETION — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-02-23 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-22 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RHINORRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 166.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RHINORRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-07-09 (study day 166.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-26 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-03-22 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH ERYTHEMATOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PERSPIRATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONTUSION — outcome: RECOVERED/RESOLVED; onset 2013-09-05 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-04 (study day 7.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EPISTAXIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-30 (study day 33.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FEELING ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-15 (study day 18.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild LIBIDO DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild LISTLESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-24 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-01 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-31 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PHARYNGOLARYNGEAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRODUCTIVE COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 5.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RESPIRATORY TRACT CONGESTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-23 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RHINITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-23 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild STOMACH DISCOMFORT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-23 (study day 33.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CYST — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-13 (study day -9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DEPRESSED MOOD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSPHONIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-11-03 (study day 166.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-09-12 (study day 114.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ONYCHOMYCOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-13 (study day -9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-22 (study day 21.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-02 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-25 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2012-12-25 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-26 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-02 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-05 (study day 6.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-16 (study day 48.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 137.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BACK PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-13 (study day 137.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 1986; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 1986; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-06-14 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PAIN — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 93.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHEST DISCOMFORT — outcome: RECOVERED/RESOLVED; onset 2013-06-24 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2013-07-17 (study day 164.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-06-24 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-03-18 (study day 7.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2014-03-18 (study day 7.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-03-16 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 168.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MICTURITION URGENCY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-02 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-21 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-21 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-21 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-01-21 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-10 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-04 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PARAESTHESIA — outcome: RECOVERED/RESOLVED; onset 2013-02-08 (study day 35.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-09-09 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NEUTROPHIL COUNT INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NEUTROPHIL COUNT INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RECTAL HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RECTAL HAEMORRHAGE — outcome: RECOVERED/RESOLVED; onset 2013-09-02 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINE ANALYSIS ABNORMAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINE ANALYSIS ABNORMAL — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WHITE BLOOD CELL COUNT INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WHITE BLOOD CELL COUNT INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day -19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-03-04 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-03-05 (study day 4.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BENIGN PROSTATIC HYPERPLASIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BIOPSY PROSTATE — outcome: RECOVERED/RESOLVED; onset 2013-11-16 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERCHOLESTEROLAEMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2007; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-25 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2012-09-13 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHILLS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-09 (study day 38.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHILLS — outcome: RECOVERED/RESOLVED; onset 2012-10-09 (study day 38.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-04-05 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CATARACT OPERATION — outcome: RECOVERED/RESOLVED; onset 2013-04-25 (study day 44.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-28 (study day -13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-02-28 (study day -13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-17 (study day 127.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-07-17 (study day 127.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 76.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 25.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 25.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 74.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 74.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-18 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-22 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-22 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DECREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DECREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DISORIENTATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 18.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-09-04 (study day 47.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2001; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2001; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-11 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-08-11 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-28 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate GLAUCOMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 1992; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-13 (study day 183.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 171.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-09-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-15 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: RECOVERED/RESOLVED; onset 2014-03-15 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHEST DISCOMFORT — outcome: RECOVERED/RESOLVED; onset 2012-12-15 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2012-12-13 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2012-12-13 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate WEIGHT DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate WEIGHT DECREASED — outcome: RECOVERED/RESOLVED; onset 2012-12-12 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-30 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-25 (study day 44.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 40.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-17 (study day 22.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 10.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALAISE — outcome: RECOVERED/RESOLVED; onset 2013-09-05 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-09-22 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-14 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CYSTITIS — outcome: RECOVERED/RESOLVED; onset 2014-02-27 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-07-05 (study day 135.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN LACERATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-06 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-07-05 (study day 135.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CARDIAC DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-01 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2013-11-01 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-19 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-11-05 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-19 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PALPITATIONS — outcome: RECOVERED/RESOLVED; onset 2013-09-28 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VERTIGO — outcome: RECOVERED/RESOLVED; onset 2013-09-28 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WOLFF-PARKINSON-WHITE SYNDROME — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WOLFF-PARKINSON-WHITE SYNDROME — outcome: RECOVERED/RESOLVED; onset 2013-10-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ABDOMINAL DISCOMFORT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-26 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-11-17 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-12-15 (study day 53.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-11-17 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALAISE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 4.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-24 (study day 62.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-09 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-22 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLOOD GLUCOSE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLOOD GLUCOSE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-03-30 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-04 (study day 51.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-23 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-23 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-28 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-12-28 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-27 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-27 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-23 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-23 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-08 (study day 39.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

Severe RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-08 (study day 39.0); relationship: not assessed

Historical record imported from the SDTM AE domain (assessed at source).

Mild INFLUENZA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-27 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INFLUENZA — outcome: RECOVERED/RESOLVED; onset 2012-09-27 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA PERIPHERAL — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLOOD GLUCOSE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-30 (study day 42.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSPNOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-28 (study day 35.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-14 (study day -11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-08 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2013-11-08 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FLUTTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FLUTTER — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLISTER — outcome: RECOVERED/RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-10-17 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-06 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-12-06 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-09 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-11-09 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-11-15 (study day 34.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SEASONAL ALLERGY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-06 (study day -7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-04 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VIRAL INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-07-30 (study day 23.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-04 (study day 73.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-23 (study day 31.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BURNING SENSATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-03 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-18 (study day 41.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-01-18 (study day 41.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FLATULENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FLATULENCE — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild POLLAKIURIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild POLLAKIURIA — outcome: RECOVERED/RESOLVED; onset 2013-10-27 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-23 (study day -106.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PARKINSON'S DISEASE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-06 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe COMPLETED SUICIDE — outcome: FATAL; onset 2014-10-31 (study day 174.0); relationship: NONE; serious criteria: death

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-02 (study day 90.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERBILIRUBINAEMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-26 (study day 19.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-17 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DYSPEPSIA — outcome: RECOVERED/RESOLVED; onset 2013-09-17 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 94.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-30 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-13 (study day 123.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2014-02-05 (study day 52.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-14 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate WOUND HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-09 (study day 69.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-04-08 (study day 30.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR HYPERTROPHY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-25 (study day 169.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-04-11 (study day 33.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2012-09-19 (study day 13.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Severe COLON CANCER — outcome: RECOVERED/RESOLVED; onset 2013-01-21 (study day 137.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2011-12-05 (study day -277.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2011-12-05 (study day -277.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ANXIETY — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH ERYTHEMATOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-22 (study day -1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-05; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-05; relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-07 (study day 8.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EXCORIATION — outcome: RECOVERED/RESOLVED; onset 2014-01-14 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate IRRITABILITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate IRRITABILITY — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-04 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-03-04 (study day 64.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-06-03 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 36.0); relationship: PROBABLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate EXCORIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate EXCORIATION — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-15 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2012-09-23 (study day 9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLOOD CREATINE PHOSPHOKINASE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-26 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLOOD CREATINE PHOSPHOKINASE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-11-26 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONJUNCTIVITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONJUNCTIVITIS — outcome: RECOVERED/RESOLVED; onset 2014-02-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild POSTNASAL DRIP — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-03 (study day 37.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild POSTNASAL DRIP — outcome: RECOVERED/RESOLVED; onset 2013-12-03 (study day 37.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS ARRHYTHMIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS ARRHYTHMIA — outcome: RECOVERED/RESOLVED; onset 2013-11-25 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-12-31 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe STUPOR — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VISION BLURRED — outcome: RECOVERED/RESOLVED; onset 2014-01-01 (study day 13.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-02-26 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-05-23 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-06-09 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-23 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-06-23 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-04 (study day 106.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 118.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE IRREGULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE IRREGULAR — outcome: RECOVERED/RESOLVED; onset 2013-01-19 (study day 90.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE IRREGULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-16 (study day 146.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE IRREGULAR — outcome: RECOVERED/RESOLVED; onset 2013-03-16 (study day 146.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-25 (study day 18.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-03-22 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ALCOHOL USE — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild CYSTITIS — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Severe DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2014-03-24 (study day 86.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild FLANK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-19 (study day -10.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2014-03-01 (study day 63.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2013-02-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-06 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONJUNCTIVITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONJUNCTIVITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-05-06 (study day -1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-07 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEART RATE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-02-27 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-02-11 (study day 6.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-07 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-03-07 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HOT FLUSH — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 42.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe MUSCLE SPASMS — outcome: RECOVERED/RESOLVED; onset 2013-02-18 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-01 (study day 24.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-21 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-02-21 (study day 16.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 162.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-12 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONSTIPATION — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 162.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-23 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-04 (study day 83.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-09-04 (study day 83.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-04 (study day 113.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-10-04 (study day 113.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL HYPERTROPHY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-27 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIAL HYPERTROPHY — outcome: RECOVERED/RESOLVED; onset 2013-06-27 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PAIN IN EXTREMITY — outcome: RECOVERED/RESOLVED; onset 2013-12-07 (study day 177.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 68.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-02 (study day 68.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-08 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-15 (study day 177.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-29 (study day 160.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-12 (study day 37.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-10 (study day 125.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2012-12-18 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-02 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE SWELLING — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-06-13 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-01 (study day 119.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-08-18 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-18 (study day 46.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-08-28 (study day 56.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-10 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-16 (study day 173.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-16 (study day 173.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE WARMTH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE WARMTH — outcome: RECOVERED/RESOLVED; onset 2013-12-10 (study day 32.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EPISTAXIS — outcome: RECOVERED/RESOLVED; onset 2013-11-22 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-16 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-08-16 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2012-08-30 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2013-01-03 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-15 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-01-03 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-17 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MUSCLE SPASMS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-24 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MUSCLE SPASMS — outcome: RECOVERED/RESOLVED; onset 2013-01-24 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-09 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-01-09 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 86.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-15 (study day 142.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PHARYNGEAL ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PHARYNGEAL ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 139.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-19 (study day 177.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 86.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-12 (study day 170.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-01 (study day 104.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-07 (study day 80.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-08 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-02 (study day 113.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ACROCHORDON EXCISION — outcome: RECOVERED/RESOLVED; onset 2014-03-23 (study day 150.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-12 (study day 19.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-06 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-11-06 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-11 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE VESICLES — outcome: RECOVERED/RESOLVED; onset 2013-03-26 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 65.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-09-06 (study day 36.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-17 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-08-17 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-03-26 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-20 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-03-27 (study day 24.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-01 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-04-01 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-05-17 (study day 75.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 85.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DISCHARGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 16.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-28 (study day 14.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-05-31 (study day 17.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN LESION EXCISION — outcome: RECOVERED/RESOLVED; onset 2013-06-28 (study day 45.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BENIGN PROSTATIC HYPERPLASIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Severe BENIGN PROSTATIC HYPERPLASIA — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLOOD URINE PRESENT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-14 (study day 48.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CYSTOSCOPY — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DEHYDRATION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild LOCALISED INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild LOCALISED INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ORTHOSTATIC HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ORTHOSTATIC HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-19 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEMIANOPIA HOMONYMOUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-14 (study day 22.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-19 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIABETES MELLITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-30 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-04 (study day 91.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-05-04 (study day 91.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DRUG ERUPTION — outcome: RECOVERED/RESOLVED; onset 2014-05-20 (study day 107.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2014-04-20 (study day 77.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ALLERGIC GRANULOMATOUS ANGIITIS — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-28 (study day 40.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BIOPSY — outcome: RECOVERED/RESOLVED; onset 2013-06-26 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-01 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-07-01 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FEELING COLD — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-06 (study day 80.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NIGHTMARE — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH MACULO-PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-10 (study day -9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH MACULO-PAPULAR — outcome: RECOVERED/RESOLVED; onset 2013-06-10 (study day -9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH MACULO-PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-20 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH PAPULAR — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH PAPULAR — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-19 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-06-19 (study day 1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-17 (study day 28.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-10-19 (study day 183.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE BLEEDING — outcome: RECOVERED/RESOLVED; onset 2013-06-07 (study day 64.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-12 (study day 99.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 47.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 47.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-25 (study day 11.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2013-08-25 (study day 11.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLOOD ALKALINE PHOSPHATASE INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 141.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2011-11; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-07 (study day 5.0); relationship: POSSIBLE; serious criteria: life-threatening

Mild TRANSIENT ISCHAEMIC ATTACK — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-16 (study day 3.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild TRANSIENT ISCHAEMIC ATTACK — outcome: RECOVERED/RESOLVED; onset 2014-01-16 (study day 3.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-02-18 (study day 9.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-04-16 (study day 66.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate FACIAL BONES FRACTURE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-08-08 (study day 180.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NEPHROLITHIASIS — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 67.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-18 (study day 98.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SALIVARY HYPERSECRETION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-29 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-06-29 (study day 140.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-01 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 67.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHEST PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 14.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-10-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HAEMOPTYSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HAEMOPTYSIS — outcome: RECOVERED/RESOLVED; onset 2014-05-09 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RALES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-23 (study day 85.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RALES — outcome: RECOVERED/RESOLVED; onset 2014-05-23 (study day 85.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-03 (study day 62.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-08-03 (study day 62.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-22 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-07-22 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN EXFOLIATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day 72.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN EXFOLIATION — outcome: RECOVERED/RESOLVED; onset 2013-08-13 (study day 72.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-07-02 (study day 30.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-06-22 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-01-28 (study day 34.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE INDURATION — outcome: RECOVERED/RESOLVED; onset 2013-01-21 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-23 (study day 23.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-01-31 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-02-08 (study day 39.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FALL — outcome: RECOVERED/RESOLVED; onset 2013-02-09 (study day 40.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-04 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-01-04 (study day 4.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2013-01-02 (study day 2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe GASTROINTESTINAL HAEMORRHAGE — outcome: RECOVERED/RESOLVED; onset 2013-02-05 (study day 151.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Severe HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-01-22 (study day 137.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-12 (study day 96.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-06 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-12 (study day 57.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2013-12-12 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1977; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ARTHRITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1977; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-27 (study day 41.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe MYOCARDIAL INFARCTION — outcome: FATAL; onset 2013-08-02 (study day 12.0); relationship: POSSIBLE; serious criteria: hospitalization, death, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-13 (study day 34.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-13 (study day 3.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VERTIGO — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-04 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2012-10-04 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2012-10-04 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2012-10-19 (study day 18.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2012-10-14 (study day 13.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE VASOVAGAL — outcome: RECOVERED/RESOLVED; onset 2012-10-19 (study day 18.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COMPLEX PARTIAL SEIZURES — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Moderate FALL — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN LACERATION — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-19 (study day 110.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-03-20 (study day 111.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIOVENTRICULAR BLOCK FIRST DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-10 (study day 115.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-10 (study day 115.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-23 (study day 44.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-29 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2012-11-22 (study day 58.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-13 (study day 110.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-11 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2014-02-18 (study day 53.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-24 (study day 118.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-09-29 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 119.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CHILLS — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 121.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-09-29 (study day 109.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 119.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COLD SWEAT — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 121.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-07-03 (study day 21.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-21 (study day 70.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-21 (study day 70.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-23 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ATRIAL FIBRILLATION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CARDIAC FAILURE CONGESTIVE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-22 (study day 57.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DYSPNOEA — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPONATRAEMIA — outcome: RECOVERED/RESOLVED; onset 2012-11-22 (study day 57.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Severe MYOCARDIAL INFARCTION — outcome: RECOVERED/RESOLVED; onset 2012-11-21 (study day 56.0); relationship: POSSIBLE; serious criteria: hospitalization, life-threatening

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BURNING SENSATION — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-07 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-02-07 (study day 46.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SOMNOLENCE — outcome: RECOVERED/RESOLVED; onset 2013-01-13 (study day 21.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-03-02 (study day 69.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-13 (study day 61.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-10 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-10 (study day 58.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-31 (study day 48.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-05-20 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-02-26 (study day -1.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-14 (study day 77.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-05-14 (study day 77.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: RECOVERED/RESOLVED; onset 2013-06-18 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-30 (study day 50.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-14 (study day 96.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DESQUAMATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-24 (study day 130.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-22 (study day 97.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-22 (study day 97.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DELUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-26 (study day 155.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Severe HIP FRACTURE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-25 (study day 64.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Severe HIP FRACTURE — outcome: RECOVERED/RESOLVED; onset 2013-12-25 (study day 64.0); relationship: NONE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild PSYCHOMOTOR HYPERACTIVITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-26 (study day 155.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ATRIAL FIBRILLATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-18 (study day 113.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ATRIOVENTRICULAR BLOCK FIRST DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-26 (study day 29.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-18 (study day 113.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-18 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-27 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SUPRAVENTRICULAR TACHYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SUPRAVENTRICULAR TACHYCARDIA — outcome: RECOVERED/RESOLVED; onset 2012-11-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-24 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-02-24 (study day 51.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-31 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-01-31 (study day 27.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-16 (study day 14.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE URTICARIA — outcome: RECOVERED/RESOLVED; onset 2013-04-29 (study day 27.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-27 (study day 25.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-04 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2012-08-04 (study day 7.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild GLOSSITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-12 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-29 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-18 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CERUMEN IMPACTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-01 (study day 60.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONJUNCTIVAL HAEMORRHAGE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 58.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Severe NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2013-04-28 (study day 26.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PARAESTHESIA ORAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-11 (study day 9.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-27 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH PRURITIC — outcome: RECOVERED/RESOLVED; onset 2013-05-27 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-29 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-04-29 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate TINNITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2007-10; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-28 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2013-05-28 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-05 (study day 10.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-23 (study day -188.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-07-23 (study day -188.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 12.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CATARACT OPERATION — outcome: RECOVERED/RESOLVED; onset 2014-03-08 (study day 175.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VOMITING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-14 (study day 107.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-30 (study day 31.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DELIRIUM — outcome: RECOVERED/RESOLVED; onset 2013-07-01 (study day 32.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH PRURITIC — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH PRURITIC — outcome: RECOVERED/RESOLVED; onset 2013-06-21 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ASTHENIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-05 (study day 28.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CERVICITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CERVICITIS — outcome: RECOVERED/RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSPEPSIA — outcome: RECOVERED/RESOLVED; onset 2013-08-22 (study day 14.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSPEPSIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-12 (study day 35.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSURIA — outcome: RECOVERED/RESOLVED; onset 2013-08-19 (study day 11.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate GASTROENTERITIS VIRAL — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 63.0); relationship: REMOTE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Mild GASTROOESOPHAGEAL REFLUX DISEASE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PELVIC PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PELVIC PAIN — outcome: RECOVERED/RESOLVED; onset 2013-10-10 (study day 63.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINARY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-28 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URINARY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-08-28 (study day 20.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VAGINAL MYCOSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VAGINAL MYCOSIS — outcome: RECOVERED/RESOLVED; onset 2013-11-23 (study day 107.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ABDOMINAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ABDOMINAL PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-30 (study day 4.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-02 (study day 7.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-31 (study day 158.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-30 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE DERMATITIS — outcome: RECOVERED/RESOLVED; onset 2012-10-30 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-02 (study day 7.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 82.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-10 (study day 165.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-10 (study day 165.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-01 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SHOULDER PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-01 (study day 126.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-19 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-03-19 (study day 60.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-27 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-03-27 (study day 68.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BRONCHITIS — outcome: RECOVERED/RESOLVED; onset 2014-07-18 (study day 93.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BUNDLE BRANCH BLOCK RIGHT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BUNDLE BRANCH BLOCK RIGHT — outcome: RECOVERED/RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-26 (study day 40.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SUPRAVENTRICULAR EXTRASYSTOLES — outcome: RECOVERED/RESOLVED; onset 2014-06-04 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 44.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-12 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-08-12 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-13 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-05-13 (study day 18.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-17 (study day 22.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DYSURIA — outcome: RECOVERED/RESOLVED; onset 2013-07-25 (study day 91.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-12 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-05-12 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-14 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ARTHRALGIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-08 (study day 95.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-24 (study day 83.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BACK PAIN — outcome: RECOVERED/RESOLVED; onset 2014-02-24 (study day 83.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COUGH — outcome: RECOVERED/RESOLVED; onset 2014-01-22 (study day 50.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-12-14 (study day 11.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-12-13 (study day 10.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-11 (study day 39.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2014-01-22 (study day 50.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-27 (study day 175.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-04 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR PAIN — outcome: RECOVERED/RESOLVED; onset 2013-04-04 (study day 38.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 111.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 111.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 93.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 93.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-30 (study day 33.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-03-30 (study day 33.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ATRIOVENTRICULAR BLOCK SECOND DEGREE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-13 (study day -2.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DERMATITIS CONTACT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DERMATITIS CONTACT — outcome: RECOVERED/RESOLVED; onset 2013-05-07 (study day 71.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-13 (study day 77.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NEPHROLITHIASIS — outcome: RECOVERED/RESOLVED; onset 2013-01-10 (study day 54.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-03-18 (study day 30.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE REACTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-21 (study day 70.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-14 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-03-14 (study day 32.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-22 (study day 71.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONFUSIONAL STATE — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PALPITATIONS — outcome: RECOVERED/RESOLVED; onset 2013-07-08 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-07-13 (study day 8.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EMPHYSEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-16 (study day 161.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NASOPHARYNGITIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-08-20 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NASOPHARYNGITIS — outcome: RECOVERED/RESOLVED; onset 2012-08-20 (study day 43.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-07-16 (study day 106.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild EAR INFECTION — outcome: RECOVERED/RESOLVED; onset 2014-08-15 (study day 136.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-31 (study day 121.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: RECOVERED/RESOLVED; onset 2014-04-18 (study day 17.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-17 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-17 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 172.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-05-21 (study day 25.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-01 (study day 54.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 366.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate LETHARGY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-31 (study day 84.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-04 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-07-04 (study day 57.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RESTLESSNESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-28 (study day 81.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate RESTLESSNESS — outcome: RECOVERED/RESOLVED; onset 2013-07-28 (study day 81.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-13 (study day 36.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-07-31 (study day 54.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ATRIAL FLUTTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BUNDLE BRANCH BLOCK RIGHT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VENTRICULAR SEPTAL DEFECT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-19 (study day 32.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLISTER — outcome: RECOVERED/RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-17 (study day 151.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe BLISTER — outcome: RECOVERED/RESOLVED; onset 2014-08-17 (study day 151.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-07-09 (study day 112.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM ST SEGMENT DEPRESSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-12 (study day 60.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-01 (study day 79.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-15 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALIGNANT FIBROUS HISTIOCYTOMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-19 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MALIGNANT FIBROUS HISTIOCYTOMA — outcome: RECOVERED/RESOLVED; onset 2013-02-19 (study day 19.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-15 (study day 43.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-25 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-17 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-10-17 (study day 16.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-09 (study day 35.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-03 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERSENSITIVITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-10 (study day 154.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERSENSITIVITY — outcome: RECOVERED/RESOLVED; onset 2013-03-10 (study day 154.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-17 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SWELLING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-17 (study day 41.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-24 (study day -9.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DELUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-24 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HALLUCINATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-11-24 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe PROSTATE CANCER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-07 (study day 122.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-05 (study day 89.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BLOOD CHOLESTEROL INCREASED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 15.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-20 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLISTER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-08 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BLISTER — outcome: RECOVERED/RESOLVED; onset 2013-06-08 (study day 62.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-04-22 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-20 (study day 24.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ABDOMINAL PAIN — outcome: RECOVERED/RESOLVED; onset 2014-07-22 (study day 70.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: RECOVERED/RESOLVED; onset 2014-05-28 (study day 15.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ULCER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-08-02 (study day 81.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-02 (study day 61.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-08-18 (study day 46.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild COGNITIVE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-14 (study day 1.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-12-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-26 (study day 145.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HEADACHE — outcome: RECOVERED/RESOLVED; onset 2013-09-26 (study day 145.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-07 (study day 3.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URTICARIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild URTICARIA — outcome: RECOVERED/RESOLVED; onset 2013-05-05 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VISION BLURRED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VISION BLURRED — outcome: RECOVERED/RESOLVED; onset 2013-07; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-11 (study day 110.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CHEST PAIN — outcome: RECOVERED/RESOLVED; onset 2014-04-05 (study day 111.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ELECTROCARDIOGRAM T WAVE INVERSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-14 (study day 89.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ERYTHEMA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-01 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-14 (study day 30.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BACK PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-05-21 (study day 128.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate COUGH — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-13 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-13 (study day -1.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate ENURESIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05; relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild IRRITABILITY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RHINORRHOEA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RHINORRHOEA — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-08 (study day 85.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-01-15 (study day 2.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-09 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: RECOVERED/RESOLVED; onset 2014-03-09 (study day 55.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-21 (study day 98.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WOUND — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-06-03 (study day 141.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild WOUND — outcome: RECOVERED/RESOLVED; onset 2014-06-03 (study day 141.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-20 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2014-02-15 (study day 20.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INCREASED APPETITE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-29 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INCREASED APPETITE — outcome: RECOVERED/RESOLVED; onset 2014-01-29 (study day 3.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INSOMNIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-22 (study day 27.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS GENERALISED — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-03-04 (study day 37.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-15 (study day 20.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VENTRICULAR EXTRASYSTOLES — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-04-18 (study day 82.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild INSOMNIA — outcome: RECOVERED/RESOLVED; onset 2013-04-17 (study day 86.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-03 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-03 (study day 13.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe RASH — outcome: RECOVERED/RESOLVED; onset 2013-04-25 (study day 94.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-01-26 (study day 5.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ALOPECIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-15 (study day 28.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-19 (study day 1.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-02-01 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FATIGUE — outcome: RECOVERED/RESOLVED; onset 2014-02-01 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NASAL CONGESTION — outcome: RECOVERED/RESOLVED; onset 2014-02-01 (study day 22.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate NAUSEA — outcome: RECOVERED/RESOLVED; onset 2014-02-28 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2014-02-28 (study day 49.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PERSPIRATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-11 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE PERSPIRATION — outcome: RECOVERED/RESOLVED; onset 2013-06-11 (study day 42.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: NOT RECOVERED/NOT RESOLVED; onset 1994-04; relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-08-10 (study day 102.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild NAUSEA — outcome: RECOVERED/RESOLVED; onset 2013-07-22 (study day 83.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate OEDEMA PERIPHERAL — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-29 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-23 (study day 23.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-07-07 (study day 68.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ANXIETY — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-15 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild ANXIETY — outcome: RECOVERED/RESOLVED; onset 2013-09-15 (study day 15.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PAIN — outcome: RECOVERED/RESOLVED; onset 2014-01-13 (study day 135.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate PAIN — outcome: NOT RECOVERED/NOT RESOLVED; onset 2014-01-28 (study day 150.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-07 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild RASH — outcome: RECOVERED/RESOLVED; onset 2013-10-07 (study day 37.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-06 (study day 36.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-10-06 (study day 36.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SKIN IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-09-19 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-18 (study day 12.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate INFLAMMATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-30 (study day 24.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).

Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-07-16 (study day 10.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Severe SYNCOPE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-30 (study day 24.0); relationship: POSSIBLE; serious criteria: hospitalization

Historical record imported from the SDTM AE domain (assessed at source).

Moderate APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONFUSIONAL STATE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2012-10-05 (study day 17.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-14 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-04-14 (study day 57.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild MYOCARDIAL INFARCTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-06 (study day 140.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-13 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 56.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild VOMITING — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 18.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Mild DIARRHOEA — outcome: RECOVERED/RESOLVED; onset 2013-11-16 (study day 182.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SOMNOLENCE — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-03 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate SOMNOLENCE — outcome: RECOVERED/RESOLVED; onset 2013-06-03 (study day 16.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: RECOVERED/RESOLVED; onset 2013-03-15 (study day 56.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE IRRITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-16 (study day 149.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-16 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-02-16 (study day 29.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-05-10 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BRADYCARDIA — outcome: RECOVERED/RESOLVED; onset 2013-05-10 (study day 112.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild FOOD CRAVING — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-06-09 (study day 142.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild SINUS BRADYCARDIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-07-31 (study day 194.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-06 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate UPPER RESPIRATORY TRACT INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-03-06 (study day 47.0); relationship: NONE

Historical record imported from the SDTM AE domain (assessed at source).

Severe AGITATION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-16 (study day 31.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BODY TEMPERATURE INCREASED — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate DIZZINESS — outcome: RECOVERED/RESOLVED; onset 2013-10-07 (study day 22.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate HYPERHIDROSIS — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild HYPERTENSION — outcome: RECOVERED/RESOLVED; onset 2013-10-11 (study day 26.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Severe SYNCOPE — outcome: RECOVERED/RESOLVED; onset 2013-10-12 (study day 27.0); relationship: PROBABLE; serious criteria: hospitalization

Moderate APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild APPLICATION SITE PRURITUS — outcome: RECOVERED/RESOLVED; onset 2013-12-29 (study day 100.0); relationship: PROBABLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate BALANCE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BALANCE DISORDER — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Mild BALANCE DISORDER — outcome: RECOVERED/RESOLVED; onset 2013-10-09 (study day 19.0); relationship: POSSIBLE

Historical record imported from the SDTM AE domain (assessed at source).

Moderate CONTUSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-10-15 (study day 25.0); relationship: REMOTE

Historical record imported from the SDTM AE domain (assessed at source).