701-1211

completed

Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimers Disease. · Phase II
701 (USA) · Dr. Reyes
consented 2012-11-15

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

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

mild assessed

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

moderate assessed

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

moderate assessed

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

mild assessed

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

moderate assessed

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

mild assessed

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

mild assessed

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

severe assessed

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

Data queries

No data queries.