LSFAE01:	Listing of Treatment-emergent Adverse Events; Safety Analysis Set (Study jjcs - core)											
Treatment Group 	Subject ID 	Age (years) / Sex / Race 	Onset Dose (unit) / Day of Last Dosea,b 	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 	ERECTILE DYSFUNCTION / Erectile Dysfunction 	21JUL2013 / 00:00 (3) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	08AUG2013 / 00:00 (21) 	 	 	Unknown 	Probable 	Not Recovered/Not Resolved / 4 / No 	
 	01-701-1034 	77 / F / White 	10 mg / 37 	ABNORMAL UTERINE BLEEDING / Abnormal Uterine Bleeding 	27AUG2014 / 00:00 (58) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	FATIGUE / Fatigue 	02NOV2014 / 00:00 (125) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	01-701-1146 	75 / F / Unknown 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	01JUN2013 / 00:00 (13) 	02JUN2013 / 23:59 (14) 	2 	Dose Reduced 	Probable 	Recovered/Resolved / 1 / No 	
 	 	 	10 mg / 37 	FATIGUE / Fatigue 	03JUN2013 / 00:00 (15) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	10JUN2013 / 00:00 (22) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	10JUN2013 / 00:00 (22) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	10JUN2013 / 00:00 (22) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	10JUN2013 / 00:00 (22) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PAIN / Application Site Pain 	22JUN2013 / 00:00 (34) 	 	 	Dose Not Changed 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	26JUN2013 / 00:00 (38) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	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 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	25AUG2013 / 00:00 (3) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	25AUG2013 / 00:00 (3) 	 	 	Drug Withdrawn 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	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 	LOWER RESPIRATORY TRACT INFECTION / Lower Respiratory Tract Infection 	12OCT2013 / 00:00 (51) 	10NOV2013 / 23:59 (80) 	30 	Not Applicable 	Not Related 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	FLANK PAIN / Flank Pain 	15DEC2013 / 00:00 (115) 	17DEC2013 / 23:59 (117) 	3 	Unknown 	Not Related 	Recovered/Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	CALCULUS URETHRAL / Calculus Urethral 	17DEC2013 / 00:00 (117) 	17DEC2013 / 23:59 (117) 	1 	Not Applicable 	Not Related 	Recovered/Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	EPISTAXIS / Epistaxis 	03JAN2014 / 00:00 (134) 	03JAN2014 / 23:59 (134) 	1 	Unknown 	Not Related 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	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 	ERYTHEMA / Erythema 	12JAN2014 / 00:00 (2) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	ERYTHEMA / Erythema 	12JAN2014 / 00:00 (2) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	SKIN ODOUR ABNORMAL / Skin Odour Abnormal 	12JAN2014 / 00:00 (2) 	 	 	Not Applicable 	Related 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	PRURITUS / Pruritus 	13JAN2014 / 00:00 (3) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	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 	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 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	20FEB2014 / 00:00 (41) 	12MAR2014 / 23:59 (61) 	21 	Drug Withdrawn 	Not Related 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	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 	FATIGUE / Fatigue 	01MAR2014 / 00:00 (50)* 	 	 	Drug Interrupted 	Related 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	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 	NAUSEA / Nausea 	13FEB2014 / 00:00 (7) 	03JUN2014 / 23:59 (117) 	111 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	NAUSEA / Nausea 	13FEB2014 / 00:00 (7) 	03JUN2014 / 23:59 (117) 	111 	Dose Rate Reduced 	Possible 	Recovered/Resolved / 0 / No 	
 	 	 	10 mg / 37 	VOMITING / Vomiting 	23FEB2014 / 00:00 (17) 	23FEB2014 / 23:59 (17) 	1 	Drug Interrupted 	Possible 	Recovered/Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	ERYTHEMA / Erythema 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	ERYTHEMA / Erythema 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 	Dose Increased 	Possible 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	PAROSMIA / Parosmia 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	PAROSMIA / Parosmia 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Unknown 	Possible 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	PRURITUS / Pruritus 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	PRURITUS / Pruritus 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 	Unknown 	Possible 	Recovered/Resolved / 5 / No 	
 	 	 	10 mg / 37 	SALIVARY HYPERSECRETION / Salivary Hypersecretion 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	SALIVARY HYPERSECRETION / Salivary Hypersecretion 	24FEB2014 / 00:00 (18) 	03JUN2014 / 23:59 (117) 	100 	Unknown 	Possible 	Recovered/Resolved / 1 / No 	
 	 	 	10 mg / 37 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Not Applicable 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Not Applicable 	Not Related 	Recovered/Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	NASAL CONGESTION / Nasal Congestion 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Dose Rate Reduced 	Not Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	NASAL CONGESTION / Nasal Congestion 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	16 	Unknown 	Not Related 	Recovered/Resolved / 2 / No 	
 	01-701-1287 	56 / F / Multiple 	10 mg / 37 	SALIVARY HYPERSECRETION / Salivary Hypersecretion 	26JAN2014 / 00:00 (2) 	 	 	Drug Interrupted 	Not Related 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	22FEB2014 / 00:00 (29) 	 	 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	09MAR2014 / 00:00 (44) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	RHINORRHOEA / Rhinorrhoea 	09JUL2014 / 00:00 (166) 	12JUL2014 / 23:59 (169) 	4 	Dose Rate Reduced 	Not Related 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	RHINORRHOEA / Rhinorrhoea 	09JUL2014 / 00:00 (166) 	12JUL2014 / 23:59 (169) 	4 	Drug Interrupted 	Not Related 	Recovered/Resolved / 0 / No 	
 	01-701-1302 	61 / M / Asian 	10 mg / 37 	APPLICATION SITE PERSPIRATION / Application Site Perspiration 	30AUG2013 / 00:00 (2) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	HYPERHIDROSIS / Hyperhidrosis 	30AUG2013 / 00:00 (2) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	STOMACH DISCOMFORT / Stomach Discomfort 	30AUG2013 / 00:00 (2) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	PAIN / Pain 	31AUG2013 / 00:00 (3) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	NASAL CONGESTION / Nasal Congestion 	01SEP2013 / 00:00 (4) 	 	 	Dose Reduced 	Not Related 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	DIZZINESS / Dizziness 	02SEP2013 / 00:00 (5) 	03SEP2013 / 23:59 (6) 	2 	Dose Rate Reduced 	Related 	Recovered/Resolved / 5 / No 	
 	 	 	10 mg / 37 	MALAISE / Malaise 	02SEP2013 / 00:00 (5) 	 	 	Not Applicable 	Related 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	MALAISE / Malaise 	02SEP2013 / 00:00 (5) 	 	 	Drug Interrupted 	Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	MYALGIA / Myalgia 	02SEP2013 / 00:00 (5) 	 	 	Drug Interrupted 	Possible 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	PHARYNGOLARYNGEAL PAIN / Pharyngolaryngeal Pain 	02SEP2013 / 00:00 (5) 	 	 	Dose Not Changed 	Not Related 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	PRODUCTIVE COUGH / Productive Cough 	02SEP2013 / 00:00 (5) 	 	 	Drug Interrupted 	Not Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	DIZZINESS / Dizziness 	04SEP2013 / 00:00 (7) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	CONTUSION / Contusion 	05SEP2013 / 00:00 (8) 	08OCT2013 / 23:59 (41) 	34 	Unknown 	Related 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	CONTUSION / Contusion 	05SEP2013 / 00:00 (8) 	08OCT2013 / 23:59 (41) 	34 	Unknown 	Related 	Recovered/Resolved / 1 / No 	
 	 	 	10 mg / 37 	HEADACHE / Headache 	15SEP2013 / 00:00 (18) 	 	 	Drug Withdrawn 	Not Related 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	EPISTAXIS / Epistaxis 	30SEP2013 / 00:00 (33) 	 	 	Unknown 	Related 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	15OCT2013 / 00:00 (48) 	 	 	Dose Increased 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	15OCT2013 / 00:00 (48) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	RESPIRATORY TRACT CONGESTION / Respiratory Tract Congestion 	23OCT2013 / 00:00 (56) 	 	 	Drug Withdrawn 	Not Related 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	RHINITIS / Rhinitis 	23OCT2013 / 00:00 (56) 	 	 	Not Applicable 	Not Related 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	FEELING ABNORMAL / Feeling Abnormal 	24OCT2013 / 00:00 (57) 	 	 	Dose Increased 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	LIBIDO DECREASED / Libido Decreased 	24OCT2013 / 00:00 (57) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	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 	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 	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 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	23MAR2013 / 00:00 (48) 	26MAR2013 / 23:59 (51) 	4 	Dose Increased 	Possible 	Recovered/Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	23MAR2013 / 00:00 (48) 	 	 	Not Applicable 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	23MAR2013 / 00:00 (48) 	 	 	Drug Interrupted 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	12APR2013 / 00:00 (68) 	 	 	Dose Rate Reduced 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	12APR2013 / 00:00 (68) 	 	 	Dose Reduced 	Possible 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	12APR2013 / 00:00 (68) 	 	 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	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 	CHEST DISCOMFORT / Chest Discomfort 	24JUN2013 / 00:00 (141) 	24JUN2013 / 23:59 (141) 	1 	Unknown 	Not Related 	Recovered/Resolved / 3 / No 	
 	 	 	10 mg / 37 	HEADACHE / Headache 	24JUN2013 / 00:00 (141) 	24JUN2013 / 23:59 (141) 	1 	Dose Rate Reduced 	Not Related 	Recovered/Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	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 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	19JAN2013 / 00:00 (15) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	19JAN2013 / 00:00 (15) 	 	 	Dose Not Changed 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	19JAN2013 / 00:00 (15) 	 	 	Dose Reduced 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	19JAN2013 / 00:00 (15) 	 	 	Drug Withdrawn 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	SALIVARY HYPERSECRETION / Salivary Hypersecretion 	19JAN2013 / 00:00 (15) 	 	 	Drug Withdrawn 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	04FEB2013 / 00:00 (31) 	 	 	Dose Rate Reduced 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE VESICLES / Application Site Vesicles 	04FEB2013 / 00:00 (31) 	 	 	Not Applicable 	Probable 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	PARAESTHESIA / Paraesthesia 	08FEB2013 / 00:00 (35) 	08FEB2013 / 23:59 (35) 	1 	Dose Not Changed 	Not Related 	Recovered/Resolved / 3 / No 	
 	01-703-1076 	69 / M / White 	10 mg / 37 	BIOPSY PROSTATE / Biopsy Prostate 	16NOV2013 / 00:00 (23) 	16NOV2013 / 23:59 (23) 	1 	Dose Reduced 	Not Related 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	BENIGN PROSTATIC HYPERPLASIA / Benign Prostatic Hyperplasia 	20NOV2013 / 00:00 (27) 	 	 	Dose Increased 	Not Related 	Not Recovered/Not Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	23NOV2013 / 00:00 (30) 	 	 	Dose Not Changed 	Probable 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	23NOV2013 / 00:00 (30) 	 	 	Dose Reduced 	Probable 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	23NOV2013 / 00:00 (30) 	 	 	Drug Interrupted 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	HYPERHIDROSIS / Hyperhidrosis 	25NOV2013 / 00:00 (32) 	 	 	Unknown 	Possible 	Not Recovered/Not Resolved / 0 / Yes 	

Key: *=imputed date, day, or duration 	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
Key: *=imputed date, day, or duration	
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.	
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.	
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..