709-1259

completed

Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimers Disease. · Phase II
709 (USA) · Dr. Novak
consented 2013-01-26

AEs

Serious

Dropout signal

–

Adverse events

mild assessed

Mild BENIGN PROSTATIC HYPERPLASIA — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

severe assessed

Severe BENIGN PROSTATIC HYPERPLASIA — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE; serious criteria: hospitalization

mild assessed

Mild BLOOD URINE PRESENT — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-03-14 (study day 48.0); relationship: NONE

mild assessed

Mild CYSTOSCOPY — outcome: RECOVERED/RESOLVED; onset 2013-03-17 (study day 51.0); relationship: NONE

mild assessed

Mild DEHYDRATION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

mild assessed

Mild HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: POSSIBLE; serious criteria: hospitalization

mild assessed

Mild LOCALISED INFECTION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

mild assessed

Mild LOCALISED INFECTION — outcome: RECOVERED/RESOLVED; onset 2013-02-05 (study day 11.0); relationship: NONE

mild assessed

Mild ORTHOSTATIC HYPOTENSION — outcome: NOT RECOVERED/NOT RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

mild assessed

Mild ORTHOSTATIC HYPOTENSION — outcome: RECOVERED/RESOLVED; onset 2013-04-20 (study day 85.0); relationship: POSSIBLE

mild assessed

Mild PYREXIA — outcome: RECOVERED/RESOLVED; onset 2013-04-13 (study day 78.0); relationship: NONE

Data queries

No data queries.