Page
|
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 701 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Placebo |
||||||||
Subject ID = 01-701-1363, Gender = F, Race = BLACK OR AFRICAN AMERICAN, AGE = 81 Years, TRT = Placebo |
||||||||
01-701-1363 |
16 |
NAUSEA |
2 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
|
48 |
APPLICATION SITE PRURITUS |
NA |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
137 |
BACK PAIN |
3 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
BACK PAIN |
3 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
|
HEADACHE |
NA |
MODERATE |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
HEADACHE |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
Subject ID = 01-701-1387, Gender = F, Race = WHITE, AGE = 87 Years, TRT = Placebo |
||||||||
01-701-1387 |
7 |
DIARRHOEA |
1 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
|
|
HYPERHIDROSIS |
1 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 701 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Placebo |
||||||||
Subject ID = 01-701-1392, Gender = M, Race = WHITE, AGE = 78 Years, TRT = Placebo |
||||||||
01-701-1392 |
140 |
UPPER RESPIRATORY TRACT INFECTION |
6 DAY |
MILD |
N |
REMOTE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
UPPER RESPIRATORY TRACT INFECTION |
6 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
Subject ID = 01-701-1415, Gender = M, Race = WHITE, AGE = 85 Years, TRT = Placebo |
||||||||
01-701-1415 |
29 |
UPPER RESPIRATORY TRACT INFECTION |
15 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
UPPER RESPIRATORY TRACT INFECTION |
15 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
71 |
MICTURITION URGENCY |
NA |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
121 |
UPPER RESPIRATORY TRACT INFECTION |
21 DAY |
MILD |
N |
REMOTE |
|
NOT RECOVERED/NOT RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 701 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Placebo |
||||||||
Subject ID = 01-701-1415, Gender = M, Race = WHITE, AGE = 85 Years, TRT = Placebo |
||||||||
01-701-1415 |
121 |
UPPER RESPIRATORY TRACT INFECTION |
21 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
|
168 |
DIARRHOEA |
1 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
Xanomeline High Dose |
||||||||
Subject ID = 01-701-1360, Gender = M, Race = WHITE, AGE = 67 Years, TRT = Xanomeline High Dose |
||||||||
01-701-1360 |
3 |
APPLICATION SITE PRURITUS |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
6 |
APPLICATION SITE VESICLES |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
Subject ID = 01-701-1383, Gender = F, Race = WHITE, AGE = 72 Years, TRT = Xanomeline High Dose |
||||||||
01-701-1383 |
4 |
APPLICATION SITE PRURITUS |
1 DAY |
MILD |
N |
PROBABLE |
|
RECOVERED/RESOLVED |
|
|
APPLICATION SITE PAIN |
1 DAY |
MILD |
N |
PROBABLE |
|
RECOVERED/RESOLVED |
|
48 |
APPLICATION SITE ERYTHEMA |
4 DAY |
MILD |
N |
POSSIBLE |
|
RECOVERED/RESOLVED |
|
|
APPLICATION SITE PRURITUS |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 701 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Xanomeline High Dose |
||||||||
Subject ID = 01-701-1383, Gender = F, Race = WHITE, AGE = 72 Years, TRT = Xanomeline High Dose |
||||||||
01-701-1383 |
48 |
APPLICATION SITE PRURITUS |
NA |
MODERATE |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
68 |
APPLICATION SITE ERYTHEMA |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE IRRITATION |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE IRRITATION |
NA |
MODERATE |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
93 |
APPLICATION SITE VESICLES |
18 DAY |
MILD |
N |
POSSIBLE |
|
RECOVERED/RESOLVED |
|
141 |
CHEST DISCOMFORT |
1 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
|
HEADACHE |
1 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
164 |
COUGH |
10 DAY |
MODERATE |
N |
NONE |
|
RECOVERED/RESOLVED |
Subject ID = 01-701-1444, Gender = M, Race = WHITE, AGE = 63 Years, TRT = Xanomeline High Dose |
||||||||
01-701-1444 |
15 |
APPLICATION SITE ERYTHEMA |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 701 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Xanomeline High Dose |
||||||||
Subject ID = 01-701-1444, Gender = M, Race = WHITE, AGE = 63 Years, TRT = Xanomeline High Dose |
||||||||
01-701-1444 |
15 |
APPLICATION SITE PRURITUS |
NA |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
SALIVARY HYPERSECRETION |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE ERYTHEMA |
NA |
MODERATE |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE PRURITUS |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
31 |
APPLICATION SITE IRRITATION |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE VESICLES |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
35 |
PARAESTHESIA |
1 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
Xanomeline Low Dose |
||||||||
Subject ID = 01-701-1442, Gender = F, Race = BLACK OR AFRICAN AMERICAN, AGE = 57 Years, TRT = Xanomeline Low Dose |
||||||||
01-701-1442 |
77 |
APPLICATION SITE PRURITUS |
NA |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 702 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Xanomeline Low Dose |
||||||||
Subject ID = 01-702-1082, Gender = F, Race = WHITE, AGE = 84 Years, TRT = Xanomeline Low Dose |
||||||||
01-702-1082 |
-19 |
WHITE BLOOD CELL COUNT INCREASED |
20 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
NEUTROPHIL COUNT INCREASED |
20 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
URINE ANALYSIS ABNORMAL |
18 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
URINE ANALYSIS ABNORMAL |
18 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
|
WHITE BLOOD CELL COUNT INCREASED |
20 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 702 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Xanomeline Low Dose |
||||||||
Subject ID = 01-702-1082, Gender = F, Race = WHITE, AGE = 84 Years, TRT = Xanomeline Low Dose |
||||||||
01-702-1082 |
-19 |
NEUTROPHIL COUNT INCREASED |
20 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
39 |
RECTAL HAEMORRHAGE |
5 DAY |
MILD |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
RECTAL HAEMORRHAGE |
5 DAY |
MILD |
N |
NONE |
|
RECOVERED/RESOLVED |
|
46 |
APPLICATION SITE IRRITATION |
16 DAY |
MILD |
N |
PROBABLE |
|
RECOVERED/RESOLVED |
|
79 |
SKIN IRRITATION |
20 DAY |
MODERATE |
N |
PROBABLE |
|
RECOVERED/RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 703 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Placebo |
||||||||
Subject ID = 01-703-1042, Gender = M, Race = WHITE, AGE = 64 Years, TRT = Placebo |
||||||||
01-703-1042 |
3 |
DIARRHOEA |
2 DAY |
MILD |
N |
POSSIBLE |
|
RECOVERED/RESOLVED |
|
4 |
INSOMNIA |
2 DAY |
MILD |
N |
REMOTE |
|
RECOVERED/RESOLVED |
Xanomeline High Dose |
||||||||
Subject ID = 01-703-1076, Gender = M, Race = WHITE, AGE = 69 Years, TRT = Xanomeline High Dose |
||||||||
01-703-1076 |
23 |
BIOPSY PROSTATE |
1 DAY |
MODERATE |
N |
NONE |
|
RECOVERED/RESOLVED |
|
27 |
BENIGN PROSTATIC HYPERPLASIA |
NA |
MODERATE |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
|
30 |
APPLICATION SITE PRURITUS |
NA |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE DERMATITIS |
NA |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE PRURITUS |
NA |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
||||||||
Listing
of Subjects With Serious Adverse Events |
||||||||
Trial Number: CDISCPILOT01, Site Number: 703 |
||||||||
Subject |
Rel Day |
Adverse |
|
|
|
|
Action |
|
ID |
of Onset |
Event |
Duration |
Intensity |
Serious |
Related |
Taken |
Outcome |
Xanomeline High Dose |
||||||||
Subject ID = 01-703-1076, Gender = M, Race = WHITE, AGE = 69 Years, TRT = Xanomeline High Dose |
||||||||
01-703-1076 |
32 |
HYPERHIDROSIS |
NA |
MILD |
N |
POSSIBLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
HYPERCHOLESTEROLAEMIA |
NA |
MODERATE |
N |
NONE |
|
NOT RECOVERED/NOT RESOLVED |
Xanomeline Low Dose |
||||||||
Subject ID = 01-703-1086, Gender = M, Race = WHITE, AGE = 71 Years, TRT = Xanomeline Low Dose |
||||||||
01-703-1086 |
12 |
APPLICATION SITE IRRITATION |
112 DAY |
MILD |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE IRRITATION |
112 DAY |
MODERATE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
|
|
APPLICATION SITE IRRITATION |
112 DAY |
SEVERE |
N |
PROBABLE |
|
NOT RECOVERED/NOT RESOLVED |
This is footnote 1 |
||||||||
Source: [Study MK9999P001: adam-adae] |
CONFIDENTIAL |