LSFAE06a:	Selected [Narrow / Broad] FDA Medical Queries; Safety Analysis Set (Study jjcs - core)									
OCMQ 	Treatment Group 	Subject ID 	Age (years) / Sex / Race 	Preferred Term / Reported Term 	Start Date / Time (Study Daya) 	End Date / Time (Study Daya) 	Action Taken With Study Treatment 	Outcome / Severity / Serious 	
Abdominal Pain 	Xanomeline High Dose 	01-701-1302 	61 / M / Asian 	STOMACH DISCOMFORT / Stomach Discomfort 	30AUG2013 / 00:00 (2) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-704-1065 	75 / M / Multiple 	ABDOMINAL DISCOMFORT / Abdominal Discomfort 	26OCT2013 / 00:00 (3) 	 	Unknown 	Not Recovered/Not Resolved / Mild / Yes 	
 	Xanomeline Low Dose 	01-705-1393 	84 / F / Native Hawaiian or other Pacific Islander 	ABDOMINAL PAIN / Abdominal Pain 	19SEP2012 / 00:00 (13) 	24SEP2012 / 23:59 (18) 	Unknown 	Recovered/Resolved / Mild / No 	
 	 	01-716-1311 	78 / M / Black or African American 	ABDOMINAL PAIN / Abdominal Pain 	22JUL2014 / 00:00 (70) 	02AUG2014 / 23:59 (81) 	Dose Rate Reduced 	Recovered/Resolved / Moderate / Yes 	
 	Placebo 	01-708-1286 	80 / F / Unknown 	ABDOMINAL PAIN / Abdominal Pain 	18FEB2014 / 00:00 (162) 	18FEB2014 / 23:59 (162) 	Unknown 	Recovered/Resolved / Mild / Yes 	
Abnormal Uterine Bleeding 	Xanomeline High Dose 	01-701-1034 	77 / F / White 	ABNORMAL UTERINE BLEEDING / Abnormal Uterine Bleeding 	27AUG2014 / 00:00 (58) 	 	Not Applicable 	Not Recovered/Not Resolved / Mild / Yes 	
Acute Coronary Syndrome 	Xanomeline High Dose 	01-704-1017 	77 / M / Asian 	MYOCARDIAL INFARCTION / Myocardial Infarction 	19OCT2013 / 00:00 (14) 	 	Drug Withdrawn 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-710-1142 	76 / F / Not reported 	MYOCARDIAL INFARCTION / Myocardial Infarction 	19OCT2012 / 00:00 (18) 	19OCT2012 / 23:59 (18) 	Not Applicable 	Recovered/Resolved / Moderate / Yes 	
 	 	01-718-1101 	82 / M / Asian 	MYOCARDIAL INFARCTION / Myocardial Infarction 	06JUL2013 / 00:00 (140) 	 	Dose Reduced 	Not Recovered/Not Resolved / Mild / No 	
 	Xanomeline Low Dose 	01-708-1348 	79 / F / Multiple 	MYOCARDIAL INFARCTION / Myocardial Infarction 	18AUG2013 / 00:00 (14) 	31AUG2013 / 23:59 (27) 	Dose Rate Reduced 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	MYOCARDIAL INFARCTION / Myocardial Infarction 	18AUG2013 / 00:00 (14) 	31AUG2013 / 23:59 (27) 	Dose Not Changed 	Recovered/Resolved / Mild / Yes 	
 	Placebo 	01-703-1299 	81 / F / Black or African American 	MYOCARDIAL INFARCTION / Myocardial Infarction 	13MAR2013 / 00:00 (183) 	 	Dose Reduced 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	01-708-1286 	80 / F / Unknown 	MYOCARDIAL INFARCTION / Myocardial Infarction 	23SEP2013 / 00:00 (14) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-710-1083 	89 / F / White 	MYOCARDIAL INFARCTION / Myocardial Infarction 	02AUG2013 / 00:00 (12) 	02AUG2013 / 23:59 (12) 	Dose Rate Reduced 	Fatal / Severe / Yes 	
Alopecia 	Placebo 	01-717-1201 	85 / F / Native Hawaiian or other Pacific Islander 	ALOPECIA / Alopecia 	15JAN2014 / 00:00 (28) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Mild / No 	
Anxiety 	Xanomeline Low Dose 	01-717-1004 	80 / F / Not reported 	ANXIETY / Anxiety 	15JAN2014 / 00:00 (2) 	 	Unknown 	Not Recovered/Not Resolved / Mild / Yes 	
Arrhythmia 	Xanomeline High Dose 	01-704-1008 	76 / F / White 	SINUS BRADYCARDIA / Sinus Bradycardia 	25FEB2013 / 00:00 (44) 	 	Dose Rate Reduced 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	01-704-1065 	75 / M / Multiple 	SINUS BRADYCARDIA / Sinus Bradycardia 	24DEC2013 / 00:00 (62) 	 	Unknown 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-704-1266 	82 / M / Multiple 	ATRIAL FLUTTER / Atrial Flutter 	27OCT2013 / 00:00 (15) 	08NOV2013 / 23:59 (27) 	Dose Reduced 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	ATRIAL FLUTTER / Atrial Flutter 	27OCT2013 / 00:00 (15) 	08NOV2013 / 23:59 (27) 	Dose Increased 	Recovered/Resolved / Mild / Yes 	
 	 	 	 	ATRIAL FIBRILLATION / Atrial Fibrillation 	08NOV2013 / 00:00 (27) 	06DEC2013 / 23:59 (55) 	Not Applicable 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	ATRIAL FIBRILLATION / Atrial Fibrillation 	08NOV2013 / 00:00 (27) 	06DEC2013 / 23:59 (55) 	Not Applicable 	Recovered/Resolved / Mild / No 	
 	 	01-710-1006 	77 / M / Asian 	SINUS BRADYCARDIA / Sinus Bradycardia 	29JUN2013 / 00:00 (140) 	04JUL2013 / 23:59 (145) 	Dose Increased 	Not Recovered/Not Resolved / Moderate / No 	
 	 	 	 	SINUS BRADYCARDIA / Sinus Bradycardia 	29JUN2013 / 00:00 (140) 	04JUL2013 / 23:59 (145) 	Not Applicable 	Recovered/Resolved / Moderate / Yes 	
 	 	01-714-1288 	77 / M / Multiple 	SINUS BRADYCARDIA / Sinus Bradycardia 	27MAY2014 / 00:00 (175) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / No 	
 	 	01-715-1319 	65 / M / Multiple 	SINUS BRADYCARDIA / Sinus Bradycardia 	18MAR2013 / 00:00 (30) 	18MAR2013 / 23:59 (30) 	Drug Interrupted 	Recovered/Resolved / Moderate / No 	
 	 	01-715-1321 	75 / F / Native Hawaiian or other Pacific Islander 	SINUS BRADYCARDIA / Sinus Bradycardia 	22APR2014 / 00:00 (71) 	 	Dose Rate Reduced 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-717-1109 	84 / M / Asian 	VENTRICULAR EXTRASYSTOLES / Ventricular Extrasystoles 	18APR2014 / 00:00 (82) 	 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-718-1101 	82 / M / Asian 	SINUS BRADYCARDIA / Sinus Bradycardia 	13APR2013 / 00:00 (56) 	12MAY2013 / 23:59 (85) 	Dose Rate Reduced 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	SINUS BRADYCARDIA / Sinus Bradycardia 	13APR2013 / 00:00 (56) 	12MAY2013 / 23:59 (85) 	Dose Reduced 	Recovered/Resolved / Mild / No 	
 	Xanomeline Low Dose 	01-708-1213 	76 / F / Unknown 	ATRIAL FIBRILLATION / Atrial Fibrillation 	22FEB2013 / 00:00 (14) 	22FEB2013 / 23:59 (14) 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	ATRIAL FIBRILLATION / Atrial Fibrillation 	22FEB2013 / 00:00 (14) 	22FEB2013 / 23:59 (14) 	Drug Interrupted 	Recovered/Resolved / Mild / No 	
 	 	01-708-1272 	82 / M / Not reported 	VENTRICULAR EXTRASYSTOLES / Ventricular Extrasystoles 	21FEB2013 / 00:00 (16) 	20MAR2013 / 23:59 (43) 	Unknown 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	VENTRICULAR EXTRASYSTOLES / Ventricular Extrasystoles 	21FEB2013 / 00:00 (16) 	20MAR2013 / 23:59 (43) 	Dose Increased 	Recovered/Resolved / Mild / No 	
 	 	01-708-1297 	61 / M / Not reported 	SINUS BRADYCARDIA / Sinus Bradycardia 	08MAY2013 / 00:00 (104) 	 	Not Applicable 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-709-1285 	87 / M / Native Hawaiian or other Pacific Islander 	SINUS BRADYCARDIA / Sinus Bradycardia 	19MAY2013 / 00:00 (57) 	 	Not Applicable 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-710-1385 	77 / M / Multiple 	SUPRAVENTRICULAR TACHYCARDIA / Supraventricular Tachycardia 	12NOV2012 / 00:00 (15) 	13NOV2012 / 23:59 (16) 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / No 	
 	 	 	 	SUPRAVENTRICULAR TACHYCARDIA / Supraventricular Tachycardia 	12NOV2012 / 00:00 (15) 	13NOV2012 / 23:59 (16) 	Dose Increased 	Recovered/Resolved / Moderate / No 	
 	 	 	 	ATRIAL FIBRILLATION / Atrial Fibrillation 	18FEB2013 / 00:00 (113) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / No 	
 	 	01-711-1143 	76 / F / Black or African American 	SUPRAVENTRICULAR EXTRASYSTOLES / Supraventricular Extrasystoles 	29APR2013 / 00:00 (27) 	15MAY2013 / 23:59 (43) 	Unknown 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	SUPRAVENTRICULAR EXTRASYSTOLES / Supraventricular Extrasystoles 	29APR2013 / 00:00 (27) 	15MAY2013 / 23:59 (43) 	Drug Interrupted 	Recovered/Resolved / Mild / No 	
 	 	 	 	VENTRICULAR EXTRASYSTOLES / Ventricular Extrasystoles 	28MAY2013 / 00:00 (56) 	01JUN2013 / 23:59 (60) 	Dose Not Changed 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	 	 	VENTRICULAR EXTRASYSTOLES / Ventricular Extrasystoles 	28MAY2013 / 00:00 (56) 	01JUN2013 / 23:59 (60) 	Unknown 	Recovered/Resolved / Moderate / Yes 	
 	 	01-715-1405 	69 / M / Unknown 	SINUS BRADYCARDIA / Sinus Bradycardia 	13JUL2013 / 00:00 (8) 	13JUL2013 / 23:59 (8) 	Unknown 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	 	 	SINUS BRADYCARDIA / Sinus Bradycardia 	13JUL2013 / 00:00 (8) 	13JUL2013 / 23:59 (8) 	Dose Not Changed 	Recovered/Resolved / Moderate / Yes 	
 	 	01-716-1094 	82 / M / Black or African American 	ATRIAL FLUTTER / Atrial Flutter 	19JAN2013 / 00:00 (32) 	 	Not Applicable 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	01-717-1004 	80 / F / Not reported 	SINUS BRADYCARDIA / Sinus Bradycardia 	08APR2014 / 00:00 (85) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / No 	
 	Placebo 	01-703-1299 	81 / F / Black or African American 	TACHYCARDIA / Tachycardia 	01MAR2013 / 00:00 (171) 	 	Dose Increased 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	TACHYCARDIA / Tachycardia 	01MAR2013 / 00:00 (171) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	01-707-1206 	65 / M / Native Hawaiian or other Pacific Islander 	SINUS ARRHYTHMIA / Sinus Arrhythmia 	25NOV2013 / 00:00 (29) 	23DEC2013 / 23:59 (57) 	Dose Rate Reduced 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	SINUS ARRHYTHMIA / Sinus Arrhythmia 	25NOV2013 / 00:00 (29) 	23DEC2013 / 23:59 (57) 	Dose Reduced 	Recovered/Resolved / Mild / Yes 	
 	 	01-714-1035 	88 / F / Black or African American 	SUPRAVENTRICULAR EXTRASYSTOLES / Supraventricular Extrasystoles 	04JUN2014 / 00:00 (49) 	17JUN2014 / 23:59 (62) 	Dose Increased 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	SUPRAVENTRICULAR EXTRASYSTOLES / Supraventricular Extrasystoles 	04JUN2014 / 00:00 (49) 	17JUN2014 / 23:59 (62) 	Drug Interrupted 	Recovered/Resolved / Mild / Yes 	
Arthralgia 	Xanomeline High Dose 	01-714-1288 	77 / M / Multiple 	ARTHRALGIA / Arthralgia 	08MAR2014 / 00:00 (95) 	 	Dose Rate Reduced 	Not Recovered/Not Resolved / Moderate / Yes 	
 	Xanomeline Low Dose 	01-701-1111 	81 / F / White 	ARTHRALGIA / Arthralgia 	13SEP2012 / 00:00 (7) 	 	Unknown 	Not Recovered/Not Resolved / Moderate / No 	
Back Pain 	Xanomeline High Dose 	01-701-1148 	57 / M / Not reported 	FLANK PAIN / Flank Pain 	15DEC2013 / 00:00 (115) 	17DEC2013 / 23:59 (117) 	Unknown 	Recovered/Resolved / Moderate / Yes 	
 	 	01-713-1141 	79 / M / White 	BACK PAIN / Back Pain 	30JUN2013 / 00:00 (31) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / Yes 	
 	 	01-714-1288 	77 / M / Multiple 	BACK PAIN / Back Pain 	24FEB2014 / 00:00 (83) 	08APR2014 / 23:59 (126) 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	BACK PAIN / Back Pain 	24FEB2014 / 00:00 (83) 	08APR2014 / 23:59 (126) 	Dose Not Changed 	Recovered/Resolved / Mild / Yes 	
 	Xanomeline Low Dose 	01-717-1004 	80 / F / Not reported 	BACK PAIN / Back Pain 	21MAY2014 / 00:00 (128) 	 	Dose Rate Reduced 	Not Recovered/Not Resolved / Moderate / No 	
 	Placebo 	01-701-1363 	81 / F / White 	BACK PAIN / Back Pain 	13OCT2013 / 00:00 (137) 	15OCT2013 / 23:59 (139) 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	BACK PAIN / Back Pain 	13OCT2013 / 00:00 (137) 	15OCT2013 / 23:59 (139) 	Dose Not Changed 	Recovered/Resolved / Mild / No 	
Bacterial Infection 	Xanomeline High Dose 	01-701-1239 	56 / M / White 	HORDEOLUM / Hordeolum 	01APR2014 / 00:00 (81)* 	 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-710-1006 	77 / M / Asian 	URINARY TRACT INFECTION / Urinary Tract Infection 	17APR2013 / 00:00 (67) 	19APR2013 / 23:59 (69) 	Dose Not Changed 	Recovered/Resolved / Mild / No 	
 	Xanomeline Low Dose 	01-701-1111 	81 / F / White 	CELLULITIS / Cellulitis 	13SEP2012 / 00:00 (7) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / Yes 	
 	Placebo 	01-701-1130 	84 / M / Other 	URINARY TRACT INFECTION / Urinary Tract Infection 	09MAR2014 / 00:00 (23) 	16MAR2014 / 23:59 (30) 	Drug Withdrawn 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	URINARY TRACT INFECTION / Urinary Tract Infection 	09MAR2014 / 00:00 (23) 	16MAR2014 / 23:59 (30) 	Drug Withdrawn 	Recovered/Resolved / Mild / No 	
 	 	01-713-1179 	64 / F / American Indian or Alaska Native 	URINARY TRACT INFECTION / Urinary Tract Infection 	28AUG2013 / 00:00 (20) 	08SEP2013 / 23:59 (31) 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	URINARY TRACT INFECTION / Urinary Tract Infection 	28AUG2013 / 00:00 (20) 	08SEP2013 / 23:59 (31) 	Unknown 	Recovered/Resolved / Mild / No 	
Cardiac Conduction Disturbance 	Xanomeline Low Dose 	01-704-1025 	81 / F / Asian 	WOLFF-PARKINSON-WHITE SYNDROME / Wolff-parkinson-white Syndrome 	25OCT2013 / 00:00 (29) 	29NOV2013 / 23:59 (64) 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	WOLFF-PARKINSON-WHITE SYNDROME / Wolff-parkinson-white Syndrome 	25OCT2013 / 00:00 (29) 	29NOV2013 / 23:59 (64) 	Not Applicable 	Recovered/Resolved / Mild / No 	
 	 	01-710-1385 	77 / M / Multiple 	ATRIOVENTRICULAR BLOCK FIRST DEGREE / Atrioventricular Block First Degree 	26NOV2012 / 00:00 (29) 	 	Not Applicable 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-716-1094 	82 / M / Black or African American 	BUNDLE BRANCH BLOCK RIGHT / Bundle Branch Block Right 	19JAN2013 / 00:00 (32) 	 	Dose Reduced 	Not Recovered/Not Resolved / Moderate / Yes 	
 	Placebo 	01-701-1023 	64 / M / Black or African American 	ATRIOVENTRICULAR BLOCK SECOND DEGREE / Atrioventricular Block Second Degree 	26AUG2012 / 00:00 (22) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-701-1047 	85 / F / Native Hawaiian or other Pacific Islander 	BUNDLE BRANCH BLOCK LEFT / Bundle Branch Block Left 	10MAR2013 / 00:00 (27) 	 	Dose Reduced 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-714-1035 	88 / F / Black or African American 	BUNDLE BRANCH BLOCK RIGHT / Bundle Branch Block Right 	26MAY2014 / 00:00 (40) 	04JUN2014 / 23:59 (49) 	Dose Increased 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	BUNDLE BRANCH BLOCK RIGHT / Bundle Branch Block Right 	26MAY2014 / 00:00 (40) 	04JUN2014 / 23:59 (49) 	Dose Reduced 	Recovered/Resolved / Mild / No 	
Confusional State 	Xanomeline High Dose 	01-713-1141 	79 / M / White 	DELIRIUM / Delirium 	01JUL2013 / 00:00 (32) 	15JUL2013 / 23:59 (46) 	Drug Withdrawn 	Recovered/Resolved / Moderate / No 	
 	 	01-717-1109 	84 / M / Asian 	CONFUSIONAL STATE / Confusional State 	20FEB2014 / 00:00 (25) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Mild / Yes 	
 	Xanomeline Low Dose 	01-701-1211 	76 / F / Other 	CONFUSIONAL STATE / Confusional State 	11JAN2013 / 00:00 (58) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / No 	
 	 	01-715-1405 	69 / M / Unknown 	CONFUSIONAL STATE / Confusional State 	08JUL2013 / 00:00 (3) 	08JUL2013 / 23:59 (3) 	Dose Rate Reduced 	Recovered/Resolved / Moderate / No 	
 	 	01-718-1079 	67 / F / White 	CONFUSIONAL STATE / Confusional State 	05OCT2012 / 00:00 (17) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Moderate / Yes 	
 	Placebo 	01-703-1210 	72 / F / Not reported 	DISORIENTATION / Disorientation 	02APR2013 / 00:00 (18) 	 	Drug Withdrawn 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-716-1044 	74 / M / Not reported 	CONFUSIONAL STATE / Confusional State 	15OCT2013 / 00:00 (172) 	 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-718-1355 	79 / M / Native Hawaiian or other Pacific Islander 	CONFUSIONAL STATE / Confusional State 	17APR2013 / 00:00 (49) 	 	Dose Not Changed 	Not Recovered/Not Resolved / Moderate / Yes 	
Constipation 	Placebo 	01-708-1286 	80 / F / Unknown 	CONSTIPATION / Constipation 	18FEB2014 / 00:00 (162) 	18FEB2014 / 23:59 (162) 	Dose Reduced 	Recovered/Resolved / Mild / Yes 	
Cough 	Xanomeline High Dose 	01-701-1275 	61 / M / White 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	Not Applicable 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	COUGH / Cough 	12MAR2014 / 00:00 (34) 	27MAR2014 / 23:59 (49) 	Not Applicable 	Recovered/Resolved / Mild / Yes 	
 	 	01-701-1302 	61 / M / Asian 	PRODUCTIVE COUGH / Productive Cough 	02SEP2013 / 00:00 (5) 	 	Drug Interrupted 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	01-701-1383 	72 / F / Native Hawaiian or other Pacific Islander 	COUGH / Cough 	17JUL2013 / 00:00 (164) 	26JUL2013 / 23:59 (173) 	Dose Increased 	Recovered/Resolved / Moderate / No 	
 	 	01-714-1288 	77 / M / Multiple 	COUGH / Cough 	22JAN2014 / 00:00 (50) 	25JAN2014 / 23:59 (53) 	Dose Not Changed 	Recovered/Resolved / Mild / Yes 	
 	Xanomeline Low Dose 	01-708-1272 	82 / M / Not reported 	COUGH / Cough 	01MAR2013 / 00:00 (24) 	07MAR2013 / 23:59 (30) 	Unknown 	Not Recovered/Not Resolved / Mild / Yes 	
 	 	 	 	COUGH / Cough 	01MAR2013 / 00:00 (24) 	07MAR2013 / 23:59 (30) 	Dose Reduced 	Recovered/Resolved / Mild / No 	
 	 	01-709-1217 	77 / M / American Indian or Alaska Native 	COUGH / Cough 	20MAR2013 / 00:00 (17) 	 	Dose Reduced 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-709-1326 	75 / F / Other 	COUGH / Cough 	12JUL2013 / 00:00 (99) 	 	Dose Increased 	Not Recovered/Not Resolved / Mild / No 	
 	 	01-717-1004 	80 / F / Not reported 	COUGH / Cough 	15JAN2014 / 00:00 (2) 	18FEB2014 / 23:59 (36) 	Dose Not Changed 	Not Recovered/Not Resolved / Moderate / No 	
 	 	 	 	COUGH / Cough 	15JAN2014 / 00:00 (2) 	18FEB2014 / 23:59 (36) 	Dose Rate Reduced 	Recovered/Resolved / Moderate / No 	
 	Placebo 	01-713-1269 	73 / M / White 	COUGH / Cough 	18APR2014 / 00:00 (82) 	 	Dose Reduced 	Not Recovered/Not Resolved / Mild / No 	
Decreased Appetite 	Placebo 	01-703-1210 	72 / F / Not reported 	DECREASED APPETITE / Decreased Appetite 	04MAY2013 / 00:00 (50) 	 	Unknown 	Not Recovered/Not Resolved / Mild / No 	
 	 	 	 	DECREASED APPETITE / Decreased Appetite 	04MAY2013 / 00:00 (50) 	 	Drug Withdrawn 	Not Recovered/Not Resolved / Moderate / No 	

Key: FMQ=FDA Medical Query 	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
Key: FMQ=FDA Medical Query	
a Study day is relative to [the start of [study treatment]]. 	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	a Study day is relative to [the start of [study treatment]].	
Note: Adverse events are coded using MedDRA version 26.0. 	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.	: Adverse events are coded using MedDRA version 26.