LSFAE03:	Listing of Treatment-emergent Adverse Events Leading to Permanent Discontinuation of Study Treatment; 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) / Day of Discontinuation or Completion of Studyb 	Relationship to Study Treatmentc 	Outcome / Toxicity Grade / Serious 	
Xanomeline High Dose 	01-701-1148 	57 / M / Not reported 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	25AUG2013 / 00:00 (3) 	 	 / 182 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-701-1239 	56 / M / White 	10 mg / 37 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	20FEB2014 / 00:00 (41) 	12MAR2014 / 23:59 (61) 	21 / 182 	Not Related 	Not Recovered/Not Resolved / 4 / Yes 	
 	01-701-1275 	61 / M / White 	10 mg / 37 	PRURITUS / Pruritus 	24FEB2014 / 00:00 (18) 	12JUN2014 / 23:59 (126) 	109 / 128 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	01-701-1302 	61 / M / Asian 	10 mg / 37 	HEADACHE / Headache 	15SEP2013 / 00:00 (18) 	 	 / 69 	Not Related 	Not Recovered/Not Resolved / 3 / No 	
 	 	 	10 mg / 37 	RESPIRATORY TRACT CONGESTION / Respiratory Tract Congestion 	23OCT2013 / 00:00 (56) 	 	 / 69 	Not Related 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	LISTLESS / Listless 	24OCT2013 / 00:00 (57) 	 	 / 69 	Possible 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-701-1383 	72 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	12APR2013 / 00:00 (68) 	 	 / 184 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	01-701-1444 	63 / M / American Indian or Alaska Native 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	19JAN2013 / 00:00 (15) 	 	 / 40 	Probable 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	SALIVARY HYPERSECRETION / Salivary Hypersecretion 	19JAN2013 / 00:00 (15) 	 	 / 40 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-704-1017 	77 / M / Asian 	10 mg / 37 	MYOCARDIAL INFARCTION / Myocardial Infarction 	19OCT2013 / 00:00 (14) 	 	 / 50 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-704-1093 	79 / M / American Indian or Alaska Native 	10 mg / 37 	RASH / Rash 	04MAY2013 / 00:00 (51) 	 	 / 98 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-705-1281 	73 / F / Not reported 	10 mg / 37 	PRURITUS / Pruritus 	30JAN2014 / 00:00 (64) 	 	 / 110 	Possible 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-705-1310 	74 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	WOUND HAEMORRHAGE / Wound Haemorrhage 	09JAN2014 / 00:00 (69) 	 	 / 83 	Possible 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-708-1347 	61 / F / White 	10 mg / 37 	ERYTHEMA / Erythema 	13JUN2013 / 00:00 (55) 	25JUN2013 / 23:59 (67) 	13 / 60 	Probable 	Recovered/Resolved / 0 / Yes 	
 	01-709-1099 	79 / F / Multiple 	10 mg / 37 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	12NOV2013 / 00:00 (19) 	 	 / 183 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-709-1168 	72 / F / American Indian or Alaska Native 	10 mg / 37 	SKIN IRRITATION / Skin Irritation 	17AUG2013 / 00:00 (16) 	06SEP2013 / 23:59 (36) 	21 / 57 	Probable 	Recovered/Resolved / 1 / No 	
 	 	 	10 mg / 37 	RASH / Rash 	06SEP2013 / 00:00 (36) 	11OCT2013 / 23:59 (71) 	36 / 57 	Probable 	Recovered/Resolved / 1 / Yes 	
 	01-709-1309 	65 / M / American Indian or Alaska Native 	10 mg / 37 	NASAL CONGESTION / Nasal Congestion 	19JUN2013 / 00:00 (1) 	20JUN2013 / 23:59 (2) 	2 / 184 	Related 	Recovered/Resolved / 2 / No 	
 	 	 	10 mg / 37 	ALLERGIC GRANULOMATOUS ANGIITIS / Allergic Granulomatous Angiitis 	04JUL2013 / 00:00 (16) 	04JUL2013 / 23:59 (16) 	1 / 184 	Not Related 	Recovered/Resolved / 5 / Yes 	
 	01-710-1006 	77 / M / Asian 	10 mg / 37 	CONTUSION / Contusion 	08AUG2013 / 00:00 (180) 	 	 / 182 	Not Related 	Not Recovered/Not Resolved / 0 / No 	
 	01-710-1021 	79 / M / Native Hawaiian or other Pacific Islander 	10 mg / 37 	CHEST PAIN / Chest Pain 	10OCT2013 / 00:00 (14) 	10OCT2013 / 23:59 (14) 	1 / 47 	Related 	Recovered/Resolved / 3 / Yes 	
 	01-710-1142 	76 / F / Not reported 	10 mg / 37 	HEADACHE / Headache 	04OCT2012 / 00:00 (3) 	06OCT2012 / 23:59 (5) 	3 / 22 	Related 	Recovered/Resolved / 1 / No 	
 	01-710-1408 	80 / M / Multiple 	10 mg / 37 	NASOPHARYNGITIS / Nasopharyngitis 	31JAN2013 / 00:00 (27) 	09FEB2013 / 23:59 (36) 	10 / 189 	Not Related 	Recovered/Resolved / 3 / Yes 	
 	01-713-1141 	79 / M / White 	10 mg / 37 	RASH PRURITIC / Rash Pruritic 	21JUN2013 / 00:00 (22) 	15JUL2013 / 23:59 (46) 	25 / 68 	Probable 	Not Recovered/Not Resolved / 4 / Yes 	
 	 	 	10 mg / 37 	RASH PRURITIC / Rash Pruritic 	21JUN2013 / 00:00 (22) 	15JUL2013 / 23:59 (46) 	25 / 68 	Probable 	Recovered/Resolved / 2 / No 	
 	 	 	10 mg / 37 	DELIRIUM / Delirium 	01JUL2013 / 00:00 (32) 	15JUL2013 / 23:59 (46) 	15 / 68 	Possible 	Recovered/Resolved / 1 / No 	
 	01-714-1288 	77 / M / Multiple 	10 mg / 37 	DIZZINESS / Dizziness 	13DEC2013 / 00:00 (10) 	13DEC2013 / 23:59 (10) 	1 / 196 	Possible 	Recovered/Resolved / 0 / Yes 	
 	01-716-1071 	78 / F / Black or African American 	10 mg / 37 	SYNCOPE / Syncope 	31JUL2013 / 00:00 (54) 	31JUL2013 / 23:59 (54) 	1 / 55 	Probable 	Recovered/Resolved / 1 / Yes 	
 	01-716-1447 	72 / F / Unknown 	10 mg / 37 	ERYTHEMA / Erythema 	14JAN2014 / 00:00 (30) 	 	 / 184 	Probable 	Not Recovered/Not Resolved / 4 / No 	
 	01-718-1371 	69 / F / Unknown 	10 mg / 37 	FATIGUE / Fatigue 	09MAY2013 / 00:00 (14) 	11MAY2013 / 23:59 (16) 	3 / 105 	Possible 	Recovered/Resolved / 1 / Yes 	
Xanomeline Low Dose 	01-701-1115 	84 / M / Black or African American 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	02DEC2012 / 00:00 (3) 	 	 / 55 	Probable 	Not Recovered/Not Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	02DEC2012 / 00:00 (3) 	 	 / 55 	Probable 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	26DEC2012 / 00:00 (27) 	26DEC2012 / 23:59 (27) 	1 / 55 	Possible 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	26DEC2012 / 00:00 (27) 	26DEC2012 / 23:59 (27) 	1 / 55 	Possible 	Recovered/Resolved / 4 / Yes 	
 	01-701-1192 	80 / F / Not reported 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	05DEC2012 / 00:00 (137) 	16DEC2012 / 23:59 (148) 	12 / 183 	Probable 	Not Recovered/Not Resolved / 4 / Yes 	
 	01-701-1211 	76 / F / Other 	10 mg / 37 	INCONTINENCE / Incontinence 	22NOV2012 / 00:00 (8) 	 	 / 61 	Not Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	 	 	10 mg / 37 	DYSPNOEA / Dyspnoea 	11JAN2013 / 00:00 (58) 	 	 / 61 	Not Related 	Not Recovered/Not Resolved / 3 / No 	
 	01-701-1317 	68 / M / Unknown 	10 mg / 37 	DYSPHONIA / Dysphonia 	03NOV2014 / 00:00 (166) 	 	 / 183 	Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-701-1360 	67 / M / Multiple 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	02AUG2013 / 00:00 (3) 	 	 / 15 	Probable 	Not Recovered/Not Resolved / 5 / No 	
 	01-703-1119 	81 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	APPLICATION SITE IRRITATION / Application Site Irritation 	16MAR2013 / 00:00 (25) 	 	 / 114 	Probable 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	PRURITUS / Pruritus 	04MAY2013 / 00:00 (74) 	 	 / 114 	Probable 	Not Recovered/Not Resolved / 3 / No 	
 	01-703-1403 	67 / M / Multiple 	10 mg / 37 	WEIGHT DECREASED / Weight Decreased 	12DEC2012 / 00:00 (1) 	19DEC2012 / 23:59 (8) 	8 / 8 	Not Related 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	WEIGHT DECREASED / Weight Decreased 	12DEC2012 / 00:00 (1) 	19DEC2012 / 23:59 (8) 	8 / 8 	Not Related 	Recovered/Resolved / 0 / Yes 	
 	 	 	10 mg / 37 	DIARRHOEA / Diarrhoea 	13DEC2012 / 00:00 (2) 	14DEC2012 / 23:59 (3) 	2 / 8 	Probable 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	VOMITING / Vomiting 	13DEC2012 / 00:00 (2) 	14DEC2012 / 23:59 (3) 	2 / 8 	Probable 	Recovered/Resolved / 0 / No 	
 	01-704-1025 	81 / F / Asian 	10 mg / 37 	PALPITATIONS / Palpitations 	28SEP2013 / 00:00 (2) 	30SEP2013 / 23:59 (4) 	3 / 64 	Related 	Recovered/Resolved / 4 / No 	
 	01-708-1272 	82 / M / Not reported 	10 mg / 37 	DIARRHOEA / Diarrhoea 	11FEB2013 / 00:00 (6) 	11FEB2013 / 23:59 (6) 	1 / 58 	Not Related 	Recovered/Resolved / 5 / Yes 	
 	01-708-1353 	87 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	DIZZINESS / Dizziness 	18AUG2013 / 00:00 (46) 	10SEP2013 / 23:59 (69) 	24 / 69 	Related 	Recovered/Resolved / 3 / Yes 	
 	01-709-1217 	77 / M / American Indian or Alaska Native 	10 mg / 37 	DIZZINESS / Dizziness 	01APR2013 / 00:00 (29) 	11APR2013 / 23:59 (39) 	11 / 114 	Possible 	Recovered/Resolved / 0 / Yes 	
 	01-710-1166 	81 / F / White 	10 mg / 37 	SYNCOPE / Syncope 	19MAR2013 / 00:00 (110) 	19MAR2013 / 23:59 (110) 	1 / 121 	Possible 	Recovered/Resolved / 3 / No 	
 	01-710-1385 	77 / M / Multiple 	10 mg / 37 	BLISTER / Blister 	27DEC2012 / 00:00 (60) 	 	 / 113 	Possible 	Not Recovered/Not Resolved / 3 / No 	
 	01-711-1143 	76 / F / Black or African American 	10 mg / 37 	NASOPHARYNGITIS / Nasopharyngitis 	28APR2013 / 00:00 (26) 	11MAY2013 / 23:59 (39) 	14 / 60 	Not Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-711-1433 	84 / F / Asian 	10 mg / 37 	ASTHENIA / Asthenia 	05FEB2013 / 00:00 (10) 	 	 / 11 	Related 	Not Recovered/Not Resolved / 0 / No 	
 	01-714-1068 	79 / F / Other 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	20SEP2013 / 00:00 (44) 	 	 / 70 	Probable 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-716-1311 	78 / M / Black or African American 	10 mg / 37 	ULCER / Ulcer 	02AUG2014 / 00:00 (81) 	 	 / 140 	Not Related 	Not Recovered/Not Resolved / 4 / Yes 	
 	01-717-1004 	80 / F / Not reported 	10 mg / 37 	SKIN IRRITATION / Skin Irritation 	09MAR2014 / 00:00 (55) 	15MAR2014 / 23:59 (61) 	7 / 184 	Probable 	Recovered/Resolved / 0 / No 	
 	01-718-1170 	80 / F / Not reported 	10 mg / 37 	DIZZINESS / Dizziness 	07OCT2013 / 00:00 (22) 	07OCT2013 / 23:59 (22) 	1 / 49 	Possible 	Recovered/Resolved / 0 / No 	
 	01-718-1250 	82 / F / Black or African American 	10 mg / 37 	CONTUSION / Contusion 	15OCT2013 / 00:00 (25) 	02NOV2013 / 23:59 (43) 	19 / 141 	Related 	Recovered/Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	APPLICATION SITE PRURITUS / Application Site Pruritus 	29DEC2013 / 00:00 (100) 	19FEB2014 / 23:59 (152) 	53 / 141 	Probable 	Not Recovered/Not Resolved / 3 / No 	
Placebo 	01-701-1047 	85 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	HIATUS HERNIA / Hiatus Hernia 	12FEB2013 / 00:00 (1) 	12FEB2013 / 23:59 (1) 	1 / 46 	Not Related 	Not Recovered/Not Resolved / 2 / No 	
 	 	 	10 mg / 37 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	06MAR2013 / 00:00 (23) 	 	 / 46 	Not Related 	Not Recovered/Not Resolved / 0 / No 	
 	01-701-1130 	84 / M / Other 	10 mg / 37 	URINARY TRACT INFECTION / Urinary Tract Infection 	09MAR2014 / 00:00 (23) 	16MAR2014 / 23:59 (30) 	8 / 183 	Not Related 	Not Recovered/Not Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	URINARY TRACT INFECTION / Urinary Tract Infection 	09MAR2014 / 00:00 (23) 	16MAR2014 / 23:59 (30) 	8 / 183 	Not Related 	Recovered/Resolved / 3 / No 	
 	 	 	10 mg / 37 	EYE PRURITUS / Eye Pruritus 	22MAY2014 / 00:00 (97) 	 	 / 183 	Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-701-1387 	87 / F / Unknown 	10 mg / 37 	HYPERHIDROSIS / Hyperhidrosis 	18MAR2014 / 00:00 (7) 	18MAR2014 / 23:59 (7) 	1 / 14 	Related 	Recovered/Resolved / 5 / Yes 	
 	01-701-1415 	85 / M / Not reported 	10 mg / 37 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	21OCT2013 / 00:00 (29) 	04NOV2013 / 23:59 (43) 	15 / 183 	Not Related 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	UPPER RESPIRATORY TRACT INFECTION / Upper Respiratory Tract Infection 	21JAN2014 / 00:00 (121) 	10FEB2014 / 23:59 (141) 	21 / 183 	Related 	Not Recovered/Not Resolved / 0 / No 	
 	 	 	10 mg / 37 	DIARRHOEA / Diarrhoea 	09MAR2014 / 00:00 (168) 	09MAR2014 / 23:59 (168) 	1 / 183 	Not Related 	Recovered/Resolved / 3 / No 	
 	01-703-1100 	84 / F / Other 	10 mg / 37 	CATARACT OPERATION / Cataract Operation 	25APR2013 / 00:00 (44) 	25APR2013 / 23:59 (44) 	1 / 186 	Not Related 	Recovered/Resolved / 3 / Yes 	
 	 	 	10 mg / 37 	OEDEMA PERIPHERAL / Oedema Peripheral 	17JUL2013 / 00:00 (127) 	14SEP2013 / 23:59 (186) 	60 / 186 	Related 	Recovered/Resolved / 5 / Yes 	
 	01-703-1210 	72 / F / Not reported 	10 mg / 37 	DISORIENTATION / Disorientation 	02APR2013 / 00:00 (18) 	 	 / 175 	Related 	Not Recovered/Not Resolved / 1 / No 	
 	 	 	10 mg / 37 	DECREASED APPETITE / Decreased Appetite 	04MAY2013 / 00:00 (50) 	 	 / 175 	Possible 	Not Recovered/Not Resolved / 3 / No 	
 	01-704-1435 	74 / M / Not reported 	10 mg / 37 	PARKINSON'S DISEASE / Parkinson's Disease 	06JAN2013 / 00:00 (51) 	 	 / 57 	Not Related 	Not Recovered/Not Resolved / 5 / Yes 	
 	01-707-1206 	65 / M / Native Hawaiian or other Pacific Islander 	10 mg / 37 	BLOOD CREATINE PHOSPHOKINASE INCREASED / Blood Creatine Phosphokinase Increased 	26NOV2013 / 00:00 (30) 	09DEC2013 / 23:59 (43) 	14 / 182 	Possible 	Recovered/Resolved / 2 / Yes 	
 	 	 	10 mg / 37 	POSTNASAL DRIP / Postnasal Drip 	03DEC2013 / 00:00 (37) 	10DEC2013 / 23:59 (44) 	8 / 182 	Not Related 	Not Recovered/Not Resolved / 4 / Yes 	
 	01-708-1316 	74 / F / American Indian or Alaska Native 	10 mg / 37 	APPLICATION SITE ERYTHEMA / Application Site Erythema 	15FEB2014 / 00:00 (177) 	 	 / 191 	Probable 	Not Recovered/Not Resolved / 1 / Yes 	
 	01-709-1259 	82 / M / Other 	10 mg / 37 	LOCALISED INFECTION / Localised Infection 	05FEB2013 / 00:00 (11) 	13FEB2013 / 23:59 (19) 	9 / 139 	Not Related 	Not Recovered/Not Resolved / 5 / No 	
 	 	 	10 mg / 37 	CYSTOSCOPY / Cystoscopy 	17MAR2013 / 00:00 (51) 	17MAR2013 / 23:59 (51) 	1 / 139 	Not Related 	Recovered/Resolved / 2 / No 	
 	01-709-1306 	60 / F / Asian 	10 mg / 37 	DRUG ERUPTION / Drug Eruption 	20MAY2014 / 00:00 (107) 	23MAY2014 / 23:59 (110) 	4 / 143 	Not Related 	Recovered/Resolved / 2 / Yes 	
 	01-710-1060 	82 / M / Other 	10 mg / 37 	APPLICATION SITE INDURATION / Application Site Induration 	21JAN2013 / 00:00 (21) 	21JAN2013 / 23:59 (21) 	1 / 186 	Possible 	Recovered/Resolved / 4 / No 	
 	01-713-1269 	73 / M / White 	10 mg / 37 	SHOULDER PAIN / Shoulder Pain 	01JUN2014 / 00:00 (126) 	 	 / 183 	Possible 	Not Recovered/Not Resolved / 4 / No 	
 	 	 	10 mg / 37 	RASH / Rash 	10JUL2014 / 00:00 (165) 	 	 / 183 	Related 	Not Recovered/Not Resolved / 2 / Yes 	
 	01-714-1375 	78 / F / Black or African American 	10 mg / 37 	ERYTHEMA / Erythema 	16JUN2013 / 00:00 (111) 	 	 / 194 	Probable 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-716-1024 	87 / F / Asian 	10 mg / 37 	NASOPHARYNGITIS / Nasopharyngitis 	20AUG2012 / 00:00 (43) 	27SEP2012 / 23:59 (81) 	39 / 196 	Not Related 	Not Recovered/Not Resolved / 4 / No 	
 	01-716-1026 	73 / F / Unknown 	10 mg / 37 	ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED / Electrocardiogram T Wave Amplitude Decreased 	31JUL2014 / 00:00 (121) 	 	 / 198 	Related 	Not Recovered/Not Resolved / 0 / Yes 	
 	01-717-1201 	85 / F / Native Hawaiian or other Pacific Islander 	10 mg / 37 	SKIN IRRITATION / Skin Irritation 	19DEC2013 / 00:00 (1) 	 	 / 65 	Probable 	Not Recovered/Not Resolved / 3 / Yes 	
 	01-718-1355 	79 / M / Native Hawaiian or other Pacific Islander 	10 mg / 37 	APPLICATION SITE DERMATITIS / Application Site Dermatitis 	20MAY2013 / 00:00 (82) 	20MAY2013 / 23:59 (82) 	1 / 183 	Probable 	Recovered/Resolved / 4 / No 	
 	 	 	10 mg / 37 	APPLICATION SITE REACTION / Application Site Reaction 	23JUN2013 / 00:00 (116) 	13AUG2013 / 23:59 (167) 	52 / 183 	Probable 	Not Recovered/Not Resolved / 3 / No 	

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.	
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.	
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..