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Listing of Subjects With Serious Adverse Events
ASaT

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
ASaT

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
ASaT

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
ASaT

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
ASaT

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
ASaT

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
ASaT

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
ASaT

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
ASaT

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