Trial Outcomes & Findings for A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (NCT NCT03141177)

NCT ID: NCT03141177

Last Updated: 2025-06-06

Results Overview

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 701 participants
• Primary outcome timeframe: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
• Results posted on: 2025-06-06

Participant Flow

701 participants randomized and 690 treated.

Participant milestones

Measure	Treatment A Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment B Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Overall Study STARTED	323	50	328
Overall Study Treated	320	50	320
Overall Study COMPLETED	242	34	210
Overall Study NOT COMPLETED	81	16	118

Reasons for withdrawal

Measure	Treatment A Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment B Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Overall Study Death	62	13	84
Overall Study Participant withdrew consent	9	2	13
Overall Study Not reported	1	0	1
Overall Study Lost to Follow-up	2	1	1
Overall Study Other reasons	4	0	11
Overall Study Participants did not start treatment period	3	0	8

Baseline Characteristics

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Baseline characteristics by cohort

Measure	Treatment A n=323 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment B n=50 Participants Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=328 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Total n=701 Participants Total of all reporting groups
Age, Continuous	61.4 Years STANDARD_DEVIATION 10.2 • n=5 Participants	60.3 Years STANDARD_DEVIATION 9.5 • n=7 Participants	60.4 Years STANDARD_DEVIATION 10.6 • n=5 Participants	60.9 Years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	16 Participants n=7 Participants	96 Participants n=5 Participants	186 Participants n=4 Participants
Sex: Female, Male Male	249 Participants n=5 Participants	34 Participants n=7 Participants	232 Participants n=5 Participants	515 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=5 Participants	13 Participants n=7 Participants	39 Participants n=5 Participants	90 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	149 Participants n=5 Participants	19 Participants n=7 Participants	151 Participants n=5 Participants	319 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	136 Participants n=5 Participants	18 Participants n=7 Participants	138 Participants n=5 Participants	292 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	0 Participants n=7 Participants	25 Participants n=5 Participants	51 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	267 Participants n=5 Participants	43 Participants n=7 Participants	266 Participants n=5 Participants	576 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=5 Participants	7 Participants n=7 Participants	31 Participants n=5 Participants	64 Participants n=4 Participants

PRIMARY outcome

Timeframe: From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

Population: All Randomized Participants of treatment A and treatment C

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Outcome measures

Measure	Treatment A n=323 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=328 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Progression Free Survival (PFS)	16.59 Months Interval 12.45 to 24.94	8.31 Months Interval 6.97 to 9.69	—

SECONDARY outcome

Timeframe: From randomization date to death date (Up to 31 months)

Population: All Randomized Participants of treatment A and treatment C

Overall Survival is defined as the time between the date of randomization and the date of death due to any cause. For participants that are alive, their survival time will be censored at the date of last contact date (or "last known alive date").

Outcome measures

Measure	Treatment A n=323 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=328 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Overall Survival (OS)	NA Months Insufficient number of participants with events.	NA Months Interval 22.6 to Insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Up to 31 Months

Population: All Randomized Participants

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants.

Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

Outcome measures

Measure	Treatment A n=323 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=328 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Objective Response Rate (ORR)	55.7 Percentage of Participants Interval 50.1 to 61.2	44.0 Percentage of Participants Interval 30.0 to 58.7	27.1 Percentage of Participants Interval 22.4 to 32.3

SECONDARY outcome

Timeframe: From first dose to 100 days following last dose (Up to 32 Months)

Population: All Treated Participants

Number of participants experiencing various types of any grade adverse events (AEs) during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Participants Experiencing Adverse Events (AEs)	319 Participants	50 Participants	317 Participants

SECONDARY outcome

Timeframe: From first to dose to 100 days following last dose (Up to 32 months)

Population: All Treated Participants

Number of participants experiencing various types of any grade serious adverse events (SAEs) during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Participants Experiencing Serious Adverse Events (SAEs)	160 Participants	28 Participants	144 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days following last dose (Up to 30 months)

Population: All Treated Participants

Number of participants experiencing various types of any grade adverse events (AEs) leading to discontinuation during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	63 Participants	15 Participants	54 Participants

SECONDARY outcome

Timeframe: From first dose to (up to 31 months) following first dose

Population: All Treated Participants

Number of deaths due to any cause during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Deaths	67 Participants	14 Participants	99 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days following last dose (Up to 30 Months)

Population: All Treated Participants

Number of participants experiencing laboratory abnormalities in hematology, serum chemistry and electrolytes with grade 3 or higher during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Participants With Laboratory Abnormalities Platelet Count: Any grade	137 Participants	27 Participants	216 Participants
Number of Participants With Laboratory Abnormalities Platelet Count: Grade 3-4	1 Participants	0 Participants	30 Participants
Number of Participants With Laboratory Abnormalities Leukocytes: Any grade	121 Participants	26 Participants	207 Participants
Number of Participants With Laboratory Abnormalities Lipase: Grade 3-4	46 Participants	20 Participants	41 Participants
Number of Participants With Laboratory Abnormalities Hypernatremia: Any grade	33 Participants	7 Participants	24 Participants
Number of Participants With Laboratory Abnormalities Hypernatremia: Grade 3-4	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Hyponatremia: Any grade	160 Participants	31 Participants	140 Participants
Number of Participants With Laboratory Abnormalities Hyponatremia: Grade 3-4	36 Participants	9 Participants	41 Participants
Number of Participants With Laboratory Abnormalities Hyperkalemia: Any grade	136 Participants	27 Participants	100 Participants
Number of Participants With Laboratory Abnormalities Hyperkalemia: Grade 3-4	16 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Abnormalities Hypokalemia: Any grade	64 Participants	8 Participants	37 Participants
Number of Participants With Laboratory Abnormalities Hypokalemia: Grade 3-4	11 Participants	0 Participants	6 Participants
Number of Participants With Laboratory Abnormalities Hypercalcemia: Any grade	40 Participants	9 Participants	58 Participants
Number of Participants With Laboratory Abnormalities Hypercalcemia: Grade 3-4	1 Participants	0 Participants	4 Participants
Number of Participants With Laboratory Abnormalities Hypocalcemia: Any grade	174 Participants	25 Participants	77 Participants
Number of Participants With Laboratory Abnormalities Hypocalcemia: Grade 3-4	6 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Hypermagnesemia: Any grade	42 Participants	9 Participants	29 Participants
Number of Participants With Laboratory Abnormalities Hypermagnesemia: Grade 3-4	12 Participants	4 Participants	7 Participants
Number of Participants With Laboratory Abnormalities Hypomagnesemia: Any grade	155 Participants	18 Participants	90 Participants
Number of Participants With Laboratory Abnormalities Hypomagnesemia: Grade 3-4	4 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities Hyperphosphatemia: Any grade	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Hyperphosphatemia: Grade 3-4	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities Hypophosphatemia: Any grade	226 Participants	34 Participants	154 Participants
Number of Participants With Laboratory Abnormalities Hemoglobin: Any grade	235 Participants	35 Participants	256 Participants
Number of Participants With Laboratory Abnormalities Hemoglobin: Grade 3-4	9 Participants	5 Participants	15 Participants
Number of Participants With Laboratory Abnormalities Leukocytes: Grade 3-4	1 Participants	0 Participants	16 Participants
Number of Participants With Laboratory Abnormalities Lymphocytes: Any grade	107 Participants	22 Participants	118 Participants
Number of Participants With Laboratory Abnormalities Lymphocytes: Grade 3-4	16 Participants	4 Participants	24 Participants
Number of Participants With Laboratory Abnormalities Neutrophil: Any grade	115 Participants	22 Participants	209 Participants
Number of Participants With Laboratory Abnormalities Neutrophil: Grade 3-4	10 Participants	2 Participants	36 Participants
Number of Participants With Laboratory Abnormalities Alkaline Phosphatase: Any grade	194 Participants	35 Participants	167 Participants
Number of Participants With Laboratory Abnormalities Alkaline Phosphatase: Grade 3-4	12 Participants	6 Participants	6 Participants
Number of Participants With Laboratory Abnormalities Aspartate Aminotransferase (AST): Any grade	260 Participants	43 Participants	235 Participants
Number of Participants With Laboratory Abnormalities Aspartate Aminotransferase (AST): Grade 3-4	25 Participants	19 Participants	8 Participants
Number of Participants With Laboratory Abnormalities Alanine Aminotransferase (ALT): Any grade	268 Participants	46 Participants	133 Participants
Number of Participants With Laboratory Abnormalities Alanine Aminotransferase (ALT): Grade 3-4	31 Participants	24 Participants	11 Participants
Number of Participants With Laboratory Abnormalities Bilirubin: Any grade	57 Participants	17 Participants	72 Participants
Number of Participants With Laboratory Abnormalities Bilirubin: Grade 3-4	3 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Abnormalities Creatinine: Any grade	221 Participants	34 Participants	211 Participants
Number of Participants With Laboratory Abnormalities Creatinine: Grade 3-4	4 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities Amylase: Any grade	48 Participants	28 Participants	41 Participants
Number of Participants With Laboratory Abnormalities Amylase: Grade 3-4	30 Participants	10 Participants	17 Participants
Number of Participants With Laboratory Abnormalities Lipase: Any grade	36 Participants	27 Participants	42 Participants
Number of Participants With Laboratory Abnormalities Hypophosphatemia: Grade 3-4	88 Participants	12 Participants	31 Participants
Number of Participants With Laboratory Abnormalities Hyperglycemia: Any grade	135 Participants	29 Participants	139 Participants
Number of Participants With Laboratory Abnormalities Hyperglycemia: Grade 3-4	8 Participants	2 Participants	4 Participants
Number of Participants With Laboratory Abnormalities Hypoglycemia: Any grade	72 Participants	10 Participants	41 Participants
Number of Participants With Laboratory Abnormalities Hypoglycemia: Grade 3-4	2 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days following last dose (Up to 30 Months)

Population: All Treated Participants

Number of participants experiencing worsening shift from baseline in any grade and grade 3-4 of laboratory values during the specified time frame.

Outcome measures

Measure	Treatment A n=320 Participants Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=50 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle	Treatment C n=320 Participants Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Number of Participants With Laboratory Values Grade Shifting From Baseline Alanine Aminotransferase (ALT): Any grade	249 Participants	43 Participants	121 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypernatremia: Any grade	33 Participants	7 Participants	24 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypokalemia: Any grade	61 Participants	8 Participants	35 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hemoglobin: Any grade	117 Participants	23 Participants	190 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hemoglobin: Grade 3-4	8 Participants	5 Participants	15 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Platelet Count: Any grade	129 Participants	24 Participants	216 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Platelet Count: Grade 3-4	2 Participants	0 Participants	30 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Leukocytes: Any grade	116 Participants	26 Participants	206 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Leukocytes: Grade 3-4	1 Participants	0 Participants	16 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Lymphocytes: Any grade	95 Participants	20 Participants	102 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Lymphocytes: Grade 3-4	15 Participants	4 Participants	23 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Neutrophil: Any grade	112 Participants	22 Participants	209 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Neutrophil: Grade 3-4	10 Participants	2 Participants	36 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Alkaline Phosphatase: Any grade	131 Participants	31 Participants	115 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Alkaline Phosphatase: Grade 3-4	9 Participants	6 Participants	5 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Aspartate Aminotransferase (AST): Any grade	245 Participants	42 Participants	177 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Aspartate Aminotransferase (AST): Grade 3-4	25 Participants	19 Participants	8 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Alanine Aminotransferase (ALT) Grade 3-4	31 Participants	24 Participants	11 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Bilirubin: Any grade	55 Participants	17 Participants	68 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Bilirubin: Grade 3-4	3 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Creatinine: Any grade	123 Participants	22 Participants	132 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Creatinine: Grade 3-4	4 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Amylase: Any grade	117 Participants	26 Participants	77 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Amylase: Grade 3-4	28 Participants	10 Participants	16 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Lipase: Any grade	127 Participants	27 Participants	114 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Lipase: Grade 3-4	42 Participants	20 Participants	40 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypernatremia: Grade 3-4	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyponatremia: Any grade	136 Participants	30 Participants	111 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyponatremia: Grade 3-4	34 Participants	8 Participants	37 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperkalemia: Any grade	111 Participants	25 Participants	82 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperkalemia: Grade 3-4	15 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypokalemia: Grade 3-4	10 Participants	0 Participants	5 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypercalcemia: Any grade	30 Participants	7 Participants	46 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypercalcemia: Grade 3-4	1 Participants	0 Participants	3 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypocalcemia: Any grade	170 Participants	25 Participants	73 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypocalcemia: Grade 3-4	6 Participants	2 Participants	2 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypermagnesemia: Any grade	38 Participants	9 Participants	26 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypermagnesemia: Grade 3-4	12 Participants	4 Participants	7 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypomagnesemia: Any grade	146 Participants	16 Participants	77 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypomagnesemia: Grade 3-4	4 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperphosphatemia: Any grade	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperphosphatemia: Grade 3-4	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypophosphatemia: Any grade	211 Participants	33 Participants	147 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypophosphatemia: Grade 3-4	85 Participants	12 Participants	31 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperglycemia: Any grade	74 Participants	17 Participants	76 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hyperglycemia: Grade 3-4	6 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypoglycemia: Any grade	67 Participants	9 Participants	37 Participants
Number of Participants With Laboratory Values Grade Shifting From Baseline Hypoglycemia: Grade 3-4	2 Participants	1 Participants	1 Participants

Adverse Events

Treatment A

Serious events: 160 serious events

Other events: 316 other events

Deaths: 67 deaths

Treatment B

Serious events: 28 serious events

Other events: 48 other events

Deaths: 14 deaths

Treatment C

Serious events: 144 serious events

Other events: 306 other events

Deaths: 99 deaths

Serious adverse events

Measure	Treatment A n=320 participants at risk Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment B n=50 participants at risk Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=320 participants at risk Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Gastrointestinal disorders Intestinal perforation	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Intussusception	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Large intestine perforation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Nausea	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Obstruction gastric	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Oesophagitis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Pancreatitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Pancreatitis acute	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Retroperitoneal haematoma	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Small intestinal perforation	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Stomatitis	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Vomiting	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Asthenia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Chills	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Condition aggravated	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Death	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Anaemia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.4% 11/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Pancytopenia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Acute myocardial infarction	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Atrial fibrillation	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Atrial tachycardia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Atrioventricular block complete	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Bradycardia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Cardiac arrest	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Cardiac failure	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Cardiac failure acute	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Cardiac failure congestive	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Cardio-respiratory arrest	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Intracardiac thrombus	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Myocardial infarction	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Myocardial ischaemia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Cardiac disorders Myocarditis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Ear and labyrinth disorders Vertigo	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Adrenal haemorrhage	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Adrenal insufficiency	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Adrenocorticotropic hormone deficiency	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hyperthyroidism	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hypophysitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hypothalamo-pituitary disorder	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hypothyroidism	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Thyroiditis acute	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Eye disorders Vision blurred	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal distension	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal hernia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal pain	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Anal fistula	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Colitis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Colitis microscopic	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Colonic fistula	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Constipation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Diarrhoea	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Dysphagia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Enteritis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Epigastric discomfort	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Inguinal hernia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Intestinal obstruction	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Face oedema	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Fatigue	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders General physical health deterioration	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Hernia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Inflammation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Malaise	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Mucosal inflammation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Necrosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Pain	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Pyrexia	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Sudden death	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Autoimmune hepatitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Bile duct stone	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Cholangitis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Cholecystitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Cholecystitis acute	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Cholestasis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatic failure	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatic function abnormal	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatitis	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatotoxicity	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Jaundice	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Portal vein thrombosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Immune system disorders Anaphylactic reaction	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Abdominal sepsis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Appendicitis perforated	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Bronchitis pneumococcal	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Campylobacter infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Cellulitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Clostridium difficile colitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Clostridium difficile infection	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Cystitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Dengue fever	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Diverticulitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Encephalitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Febrile infection	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Gastroenteritis viral	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Haematoma infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Herpes zoster	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Infectious pleural effusion	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Large intestine infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Lower respiratory tract infection	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Lung abscess	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Otitis externa	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Pneumocystis jirovecii infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Pneumonia	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.5% 8/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Pneumonia necrotising	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Pulmonary sepsis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Pyelonephritis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Respiratory tract infection	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Sepsis	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Septic shock	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Soft tissue infection	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Tuberculosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Upper respiratory tract infection	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Urinary tract infection	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Clavicle fracture	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Compression fracture	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Fall	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Femur fracture	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Infusion related reaction	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Overdose	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Radiation injury	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Spinal fracture	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Alanine aminotransferase increased	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Aspartate aminotransferase increased	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Bordetella test positive	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Ejection fraction decreased	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Escherichia test positive	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Hepatic enzyme increased	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Human rhinovirus test positive	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Influenza A virus test positive	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Liver function test abnormal	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Platelet count decreased	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Transaminases increased	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Dehydration	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Electrolyte imbalance	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyperglycaemia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyperkalaemia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypoglycaemia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyponatraemia	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Arthritis	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Back pain	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Bone lesion	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Bone pain	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Limb discomfort	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Muscular weakness	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Neck pain	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Osteolysis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Polyarthritis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	7.5% 24/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.2% 23/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer recurrent	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Altered state of consciousness	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Aphasia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Central nervous system lesion	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Cerebral haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Cerebral ischaemia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Dizziness	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Encephalopathy	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Guillain-Barre syndrome	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Haemorrhage intracranial	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Headache	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Hydrocephalus	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Ischaemic stroke	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Lethargy	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Peripheral sensorimotor neuropathy	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Presyncope	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Sciatica	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Seizure	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Syncope	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Psychiatric disorders Confusional state	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Psychiatric disorders Delirium	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Acute kidney injury	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Azotaemia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Bladder tamponade	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Haematuria	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Nephritis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Proteinuria	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Renal colic	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Renal failure	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Urinary retention	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Reproductive system and breast disorders Ovarian cyst	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Reproductive system and breast disorders Prostatitis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Asthma	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Mediastinal haemorrhage	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Dermatitis	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Peau d'orange	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Pemphigoid	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Rash	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Rash papular	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Skin ulcer	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Surgical and medical procedures Central venous catheterisation	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Surgical and medical procedures Surgery	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Arterial thrombosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Bleeding varicose vein	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Deep vein thrombosis	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Embolism	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Hypertension	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Hypotension	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Peripheral ischaemia	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Thrombosis	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Vascular occlusion	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Venous thrombosis limb	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)

Other adverse events

Measure	Treatment A n=320 participants at risk Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment B n=50 participants at risk Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD	Treatment C n=320 participants at risk Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
Blood and lymphatic system disorders Anaemia	15.0% 48/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	26.6% 85/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Leukopenia	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.5% 24/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Neutropenia	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	15.6% 50/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Blood and lymphatic system disorders Thrombocytopenia	7.8% 25/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	19.4% 62/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hyperthyroidism	9.7% 31/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Endocrine disorders Hypothyroidism	34.1% 109/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	30.0% 15/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	29.7% 95/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal distension	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal pain	15.6% 50/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.0% 9/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.8% 25/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Abdominal pain upper	6.9% 22/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.6% 21/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Colitis	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Constipation	12.2% 39/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	24.0% 12/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.8% 41/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Diarrhoea	63.1% 202/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	56.0% 28/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	47.2% 151/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Dry mouth	6.6% 21/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Dyspepsia	8.1% 26/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.5% 40/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Gastritis	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	7.8% 25/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	11.2% 36/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Nausea	26.9% 86/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	30.0% 15/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	30.9% 99/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Oral dysaesthesia	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Stomatitis	16.9% 54/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	25.6% 82/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Gastrointestinal disorders Vomiting	16.6% 53/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	20.0% 10/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	20.6% 66/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Asthenia	22.2% 71/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	26.0% 13/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.1% 58/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Chest pain	2.5% 8/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.5% 8/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Fatigue	31.9% 102/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	38.0% 19/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	35.0% 112/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Malaise	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Mucosal inflammation	20.6% 66/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	26.0% 13/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	25.0% 80/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Oedema peripheral	10.9% 35/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.8% 28/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Pain	5.0% 16/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
General disorders Pyrexia	11.9% 38/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	24.0% 12/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.8% 25/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Hepatobiliary disorders Hepatotoxicity	5.0% 16/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	20.0% 10/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Immune system disorders Hypersensitivity	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Bronchitis	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Nasopharyngitis	6.9% 22/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 5/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.4% 14/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Upper respiratory tract infection	10.9% 35/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 5/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Infections and infestations Urinary tract infection	7.2% 23/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.0% 9/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Injury, poisoning and procedural complications Infusion related reaction	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Alanine aminotransferase increased	28.1% 90/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	42.0% 21/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.8% 28/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Amylase increased	15.0% 48/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	9.1% 29/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Aspartate aminotransferase increased	25.6% 82/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	32.0% 16/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	11.2% 36/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood alkaline phosphatase increased	11.6% 37/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood bilirubin increased	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.1% 13/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood cholesterol increased	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.1% 10/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood creatinine increased	13.4% 43/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	14.0% 7/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	13.4% 43/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood sodium decreased	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood thyroid stimulating hormone decreased	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 5/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Blood thyroid stimulating hormone increased	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.2% 20/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Lipase increased	16.9% 54/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	26.0% 13/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	11.9% 38/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Lymphocyte count decreased	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.1% 10/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Neutrophil count decreased	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Platelet count decreased	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.8% 60/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Transaminases increased	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations Weight decreased	11.2% 36/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.1% 10/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Investigations White blood cell count decreased	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Decreased appetite	28.7% 92/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	30.0% 15/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	20.6% 66/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyperglycaemia	8.8% 28/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.4% 14/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyperkalaemia	6.6% 21/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypoalbuminaemia	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypocalcaemia	6.9% 22/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.2% 7/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypoglycaemia	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypokalaemia	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.4% 11/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypomagnesaemia	13.8% 44/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hyponatraemia	15.0% 48/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	16.0% 8/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.8% 28/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Metabolism and nutrition disorders Hypophosphataemia	14.4% 46/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.6% 18/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Arthralgia	18.4% 59/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	14.0% 7/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	9.1% 29/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Back pain	17.5% 56/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	22.0% 11/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	11.9% 38/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Muscle spasms	11.9% 38/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	14.0% 7/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.6% 5/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.1% 10/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.31% 1/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.62% 2/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Myalgia	5.0% 16/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	22.0% 11/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.2% 23/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Musculoskeletal and connective tissue disorders Pain in extremity	9.4% 30/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	9.1% 29/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Dizziness	10.0% 32/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.0% 9/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.9% 19/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Dysgeusia	23.8% 76/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.0% 9/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	21.9% 70/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Headache	15.6% 50/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	18.0% 9/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	11.2% 36/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Nervous system disorders Paraesthesia	3.4% 11/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.5% 8/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Psychiatric disorders Anxiety	2.5% 8/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Psychiatric disorders Depression	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.8% 9/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Psychiatric disorders Insomnia	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Proteinuria	10.3% 33/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	7.8% 25/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Renal and urinary disorders Renal failure	3.1% 10/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.2% 4/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Cough	18.1% 58/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	28.0% 14/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	15.9% 51/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Dysphonia	17.5% 56/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	14.0% 7/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.4% 11/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.4% 30/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	12.0% 6/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Epistaxis	6.9% 22/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 32/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.4% 30/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 5/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	3.4% 11/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.8% 12/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Alopecia	5.3% 17/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.0% 3/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Dry skin	6.6% 21/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.0% 2/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	40.0% 128/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	40.0% 20/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	40.6% 130/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Pruritus	18.8% 60/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	22.0% 11/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	4.7% 15/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Rash	21.6% 69/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	30.0% 15/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.1% 26/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Rash maculo-papular	8.4% 27/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	10.0% 5/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	1.9% 6/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Skin and subcutaneous tissue disorders Yellow skin	0.00% 0/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	2.0% 1/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	6.9% 22/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Hypertension	35.0% 112/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	36.0% 18/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	37.8% 121/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Vascular disorders Hypotension	4.1% 13/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	8.0% 4/50 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)	0.94% 3/320 • All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER