LSFAE05:	Listing of Treatment-emergent Adverse Events of Special Interest [- Specify AESI Grouping]; Safety Analysis Set (Study jjcs - core)												
Treatment Group 	Subject ID 	Age (years) / Sex / Race 	Onset Dose (unit) / Day of Last Dosea,b 	AE of Special Interest Category 	Preferred Term / Reported Term 	Start Date / Time (Study Dayb) 	End Date / Time (Study Dayb) 	AE Duration (Days) 	Action Taken With Study Treatment 	Relationship to Study Treatmentc 	Outcome / Toxicity Grade / Serious 	
Xanomeline High Dose 	01-701-1028 	71 / M / Asian 	10 mg / 37 	Seizure 	ERECTILE DYSFUNCTION / Erectile Dysfunction 	21JUL2013 / 00:00 (3) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-701-1034 	77 / F / White 	10 mg / 37 	Seizure 	ABNORMAL UTERINE BLEEDING / Abnormal Uterine Bleeding 	27AUG2014 / 00:00 (58) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-701-1146 	75 / F / Unknown 	10 mg / 37 	Seizure 	FATIGUE / Fatigue 	03JUN2013 / 00:00 (15) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	10JUN2013 / 00:00 (22) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	10JUN2013 / 00:00 (22) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	26JUN2013 / 00:00 (38) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE VESICLES / Application Site Vesicles 	26JUN2013 / 00:00 (38) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-701-1148 	57 / M / Not reported 	10 mg / 37 	Seizure 	LOWER RESPIRATORY TRACT INFECTION / Lower Respiratory Tract Infection 	12OCT2013 / 00:00 (51) 	10NOV2013 / 23:59 (80) 	30 	Dose Rate Reduced 	Not Related 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	ACTINIC KERATOSIS / Actinic Keratosis 	12FEB2014 / 00:00 (174) 	 	 	Dose Not Changed 	Not Related 	Not Recovered/Not Resolved / 3 / No 	
 	01-701-1239 	56 / M / White 	10 mg / 37 	Seizure 	ERYTHEMA / Erythema 	12JAN2014 / 00:00 (2) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	SKIN ODOUR ABNORMAL / Skin Odour Abnormal 	12JAN2014 / 00:00 (2) 	 	 	Not Applicable 	Related 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	20JAN2014 / 00:00 (10) 	08FEB2014 / 23:59 (29) 	20 	Dose Reduced 	Probable 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	20JAN2014 / 00:00 (10) 	08FEB2014 / 23:59 (29) 	20 	Dose Reduced 	Probable 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	Seizure 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	20FEB2014 / 00:00 (41) 	12MAR2014 / 23:59 (61) 	21 	Dose Reduced 	Not Related 	Recovered/Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	FATIGUE / Fatigue 	01MAR2014 / 00:00 (50)* 	 	 	Drug Interrupted 	Related 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	HORDEOLUM / Hordeolum 	01APR2014 / 00:00 (81)* 	 	 	Drug Interrupted 	Not Related 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-701-1275 	61 / M / White 	10 mg / 37 	Seizure 	NAUSEA / Nausea 	13FEB2014 / 00:00 (7) 	03JUN2014 / 23:59 (117) 	111 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	NAUSEA / Nausea 	13FEB2014 / 00:00 (7) 	03JUN2014 / 23:59 (117) 	111 	Dose Rate Reduced 	Possible 	Recovered/Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	ERYTHEMA / Erythema 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	PAROSMIA / Parosmia 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	Seizure 	PAROSMIA / Parosmia 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Unknown 	Possible 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	Seizure 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Not Applicable 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Not Applicable 	Not Related 	Recovered/Resolved / 2 / Yes 	
 	01-701-1287 	56 / F / Multiple 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	22FEB2014 / 00:00 (29) 	 	 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	09MAR2014 / 00:00 (44) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	01-701-1302 	61 / M / Asian 	10 mg / 37 	Seizure 	APPLICATION SITE PERSPIRATION / Application Site Perspiration 	30AUG2013 / 00:00 (2) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	Seizure 	HYPERHIDROSIS / Hyperhidrosis 	30AUG2013 / 00:00 (2) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	STOMACH DISCOMFORT / Stomach Discomfort 	30AUG2013 / 00:00 (2) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	NASAL CONGESTION / Nasal Congestion 	01SEP2013 / 00:00 (4) 	 	 	Dose Reduced 	Not Related 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	Seizure 	MALAISE / Malaise 	02SEP2013 / 00:00 (5) 	 	 	Drug Interrupted 	Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	PHARYNGOLARYNGEAL PAIN / Pharyngolaryngeal Pain 	02SEP2013 / 00:00 (5) 	 	 	Dose Not Changed 	Not Related 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	PRODUCTIVE COUGH / Productive Cough 	02SEP2013 / 00:00 (5) 	 	 	Drug Interrupted 	Not Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	DIZZINESS / Dizziness 	04SEP2013 / 00:00 (7) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	CONTUSION / Contusion 	05SEP2013 / 00:00 (8) 	08OCT2013 / 23:59 (41) 	34 	Unknown 	Related 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	Seizure 	CONTUSION / Contusion 	05SEP2013 / 00:00 (8) 	08OCT2013 / 23:59 (41) 	34 	Unknown 	Related 	Recovered/Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	EPISTAXIS / Epistaxis 	30SEP2013 / 00:00 (33) 	 	 	Unknown 	Related 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	15OCT2013 / 00:00 (48) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	15OCT2013 / 00:00 (48) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	LIBIDO DECREASED / Libido Decreased 	24OCT2013 / 00:00 (57) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	LISTLESS / Listless 	24OCT2013 / 00:00 (57) 	 	 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-701-1383 	72 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	Seizure 	APPLICATION SITE PAIN / Application Site Pain 	07FEB2013 / 00:00 (4) 	07FEB2013 / 23:59 (4) 	1 	Not Applicable 	Probable 	Recovered/Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	07FEB2013 / 00:00 (4) 	07FEB2013 / 23:59 (4) 	1 	Dose Not Changed 	Probable 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	12APR2013 / 00:00 (68) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	12APR2013 / 00:00 (68) 	 	 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	12APR2013 / 00:00 (68) 	 	 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE VESICLES / Application Site Vesicles 	07MAY2013 / 00:00 (93) 	24MAY2013 / 23:59 (110) 	18 	Drug Interrupted 	Possible 	Recovered/Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	CHEST DISCOMFORT / Chest Discomfort 	24JUN2013 / 00:00 (141) 	24JUN2013 / 23:59 (141) 	1 	Unknown 	Not Related 	Recovered/Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	COUGH / Cough 	17JUL2013 / 00:00 (164) 	26JUL2013 / 23:59 (173) 	10 	Dose Increased 	Not Related 	Recovered/Resolved / 1 / No 	
 	01-701-1444 	63 / M / American Indian or Alaska Native 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	19JAN2013 / 00:00 (15) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	19JAN2013 / 00:00 (15) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	19JAN2013 / 00:00 (15) 	 	 	Drug Withdrawn 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE IRRITATION / Application Site Irritation 	04FEB2013 / 00:00 (31) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE VESICLES / Application Site Vesicles 	04FEB2013 / 00:00 (31) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-703-1076 	69 / M / White 	10 mg / 37 	Seizure 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	23NOV2013 / 00:00 (30) 	 	 	Dose Not Changed 	Probable 	Not Recovered/Not Resolved / 4 / Yes 	
 	01-703-1258 	78 / F / Black or African American 	10 mg / 37 	Seizure 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	04SEP2012 / 00:00 (47) 	25JAN2013 / 23:59 (190) 	144 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	04SEP2012 / 00:00 (47) 	25JAN2013 / 23:59 (190) 	144 	Dose Not Changed 	Probable 	Recovered/Resolved / 4 / No 	
 	01-704-1008 	76 / F / White 	10 mg / 37 	Seizure 	HYPERHIDROSIS / Hyperhidrosis 	30JAN2013 / 00:00 (18) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	SINUS BRADYCARDIA / Sinus Bradycardia 	25FEB2013 / 00:00 (44) 	 	 	Dose Rate Reduced 	Not Related 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-704-1017 	77 / M / Asian 	10 mg / 37 	Seizure 	MYOCARDIAL INFARCTION / Myocardial Infarction 	19OCT2013 / 00:00 (14) 	 	 	Drug Withdrawn 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	CARDIAC DISORDER / Cardiac Disorder 	01NOV2013 / 00:00 (27) 	 	 	Not Applicable 	Not Related 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	05NOV2013 / 00:00 (31) 	22NOV2013 / 23:59 (48) 	18 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-704-1065 	75 / M / Multiple 	10 mg / 37 	Seizure 	ABDOMINAL DISCOMFORT / Abdominal Discomfort 	26OCT2013 / 00:00 (3) 	 	 	Unknown 	Related 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	27OCT2013 / 00:00 (4) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	MALAISE / Malaise 	09NOV2013 / 00:00 (17) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	CHILLS / Chills 	17NOV2013 / 00:00 (25) 	17NOV2013 / 23:59 (25) 	1 	Dose Rate Reduced 	Related 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	Seizure 	DIZZINESS / Dizziness 	17NOV2013 / 00:00 (25) 	17NOV2013 / 23:59 (25) 	1 	Not Applicable 	Related 	Recovered/Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	DIARRHOEA / Diarrhoea 	15DEC2013 / 00:00 (53) 	15DEC2013 / 23:59 (53) 	1 	Dose Reduced 	Related 	Recovered/Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	SINUS BRADYCARDIA / Sinus Bradycardia 	24DEC2013 / 00:00 (62) 	 	 	Unknown 	Not Related 	Not Recovered/Not Resolved / 1 / No 	
 	01-704-1074 	80 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	Seizure 	ERYTHEMA / Erythema 	09FEB2014 / 00:00 (19) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-704-1093 	79 / M / American Indian or Alaska Native 	10 mg / 37 	Seizure 	BLOOD GLUCOSE INCREASED / Blood Glucose Increased 	30MAR2013 / 00:00 (16) 	13APR2013 / 23:59 (30) 	15 	Not Applicable 	Not Related 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	BLOOD GLUCOSE INCREASED / Blood Glucose Increased 	30MAR2013 / 00:00 (16) 	13APR2013 / 23:59 (30) 	15 	Not Applicable 	Not Related 	Recovered/Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	04MAY2013 / 00:00 (51) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	RASH / Rash 	04MAY2013 / 00:00 (51) 	 	 	Drug Withdrawn 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-704-1266 	82 / M / Multiple 	10 mg / 37 	Seizure 	ERYTHEMA / Erythema 	17OCT2013 / 00:00 (5) 	23DEC2013 / 23:59 (72) 	68 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	ATRIAL FLUTTER / Atrial Flutter 	27OCT2013 / 00:00 (15) 	08NOV2013 / 23:59 (27) 	13 	Dose Increased 	Not Related 	Recovered/Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	ATRIAL FIBRILLATION / Atrial Fibrillation 	08NOV2013 / 00:00 (27) 	06DEC2013 / 23:59 (55) 	29 	Not Applicable 	Not Related 	Recovered/Resolved / 3 / No 	
 	 	 	10 mg / 37 	Seizure 	HYPERHIDROSIS / Hyperhidrosis 	09NOV2013 / 00:00 (28) 	04DEC2013 / 23:59 (53) 	26 	Dose Rate Reduced 	Possible 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	Seizure 	BLISTER / Blister 	15NOV2013 / 00:00 (34) 	14DEC2013 / 23:59 (63) 	30 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	15NOV2013 / 00:00 (34) 	23DEC2013 / 23:59 (72) 	39 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	15NOV2013 / 00:00 (34) 	23DEC2013 / 23:59 (72) 	39 	Dose Rate Reduced 	Probable 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	Seizure 	ERYTHEMA / Erythema 	06DEC2013 / 00:00 (55) 	23DEC2013 / 23:59 (72) 	18 	Not Applicable 	Probable 	Recovered/Resolved / 5 / No 	
 	01-705-1280 	56 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	20APR2014 / 00:00 (94) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	01-705-1281 	73 / F / Not reported 	10 mg / 37 	Seizure 	EXCORIATION / Excoriation 	30JAN2014 / 00:00 (64) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	30JAN2014 / 00:00 (64) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	30JAN2014 / 00:00 (64) 	 	 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-708-1216 	78 / M / Asian 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	06NOV2012 / 00:00 (14) 	13DEC2012 / 23:59 (51) 	38 	Dose Reduced 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	01-708-1336 	73 / M / Other 	10 mg / 37 	Seizure 	DIZZINESS / Dizziness 	18DEC2012 / 00:00 (12) 	18DEC2012 / 23:59 (12) 	1 	Not Applicable 	Possible 	Recovered/Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	Seizure 	DIZZINESS / Dizziness 	02FEB2013 / 00:00 (58) 	02FEB2013 / 23:59 (58) 	1 	Dose Increased 	Possible 	Recovered/Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	10APR2013 / 00:00 (125) 	05JUN2013 / 23:59 (181) 	57 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	10APR2013 / 00:00 (125) 	05JUN2013 / 23:59 (181) 	57 	Dose Not Changed 	Probable 	Recovered/Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	10APR2013 / 00:00 (125) 	05JUN2013 / 23:59 (181) 	57 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-708-1347 	61 / F / White 	10 mg / 37 	Seizure 	APPLICATION SITE SWELLING / Application Site Swelling 	13JUN2013 / 00:00 (55) 	25JUN2013 / 23:59 (67) 	13 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 3 / No 	
 	01-709-1099 	79 / F / Multiple 	10 mg / 37 	Seizure 	NASOPHARYNGITIS / Nasopharyngitis 	06NOV2013 / 00:00 (13) 	17NOV2013 / 23:59 (24) 	12 	Dose Reduced 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	12NOV2013 / 00:00 (19) 	 	 	Drug Withdrawn 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	APPLICATION SITE PRURITUS / Application Site Pruritus 	12NOV2013 / 00:00 (19) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 4 / No 	
 	01-709-1168 	72 / F / American Indian or Alaska Native 	10 mg / 37 	Seizure 	PRURITUS / Pruritus 	06SEP2013 / 00:00 (36) 	11OCT2013 / 23:59 (71) 	36 	Not Applicable 	Probable 	Recovered/Resolved / 3 / Yes 	
 	01-709-1309 	65 / M / American Indian or Alaska Native 	10 mg / 37 	Seizure 	NASAL CONGESTION / Nasal Congestion 	19JUN2013 / 00:00 (1) 	20JUN2013 / 23:59 (2) 	2 	Drug Withdrawn 	Related 	Recovered/Resolved / 2 / No 	
 	 	 	10 mg / 37 	Seizure 	NIGHTMARE / Nightmare 	19JUN2013 / 00:00 (1) 	20JUN2013 / 23:59 (2) 	2 	Unknown 	Related 	Recovered/Resolved / 0 / No 	
 	 	 	10 mg / 37 	Seizure 	VOMITING / Vomiting 	19JUN2013 / 00:00 (1) 	19JUN2013 / 23:59 (1) 	1 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	Seizure 	RASH MACULO-PAPULAR / Rash Maculo-Papular 	20JUN2013 / 00:00 (2) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	

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Key: *=imputed date, day, or duration	
a Study day of last administration of [study treatment] prior to or on AE start date. 	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	a Study day of last administration of [study treatment] prior to or on AE start date.	
b Study day is relative to [the start of [study treatment]]. 	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	b Study day is relative to [the start of [study treatment]].	
c Relationship is assessed by the investigator. 	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	c Relationship is assessed by the investigator.	
Note: Adverse events are coded using MedDRA version 26.0; toxicity grade is evaluated according to NCI-CTCAE version 5.0.. 	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	: Adverse events are coded using MedDRA version 26; toxicity grade is evaluated according to NCI-CTCAE version 5..	
[lsfae05.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2026, 15:11 	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11	[lsfae5.rtf][/usr/lib/rstudio-server/bin/quarto/share/rmd/rmd.R] 12JAN2.03e+03, 15:11