Trial Outcomes & Findings for PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma (NCT NCT01621490)

Last Updated: 2024-04-23

Results Overview

Biomarkers examined were percent positive CD8 and percent positive CD4, both using the Mosaic Singleplex IHC assay. Analyses are presented with the medians at baseline and on-treatment, rather than the median change because the baseline values differed across groups. Baseline was defined as the last non-missing value on or prior to the first dose of study therapy. Biopsies were also collected on treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

170 participants

Primary outcome timeframe

From last non-missing value prior to first dose to week 4 day 1

Results posted on

2024-04-23

Participant Flow

170 participants were treated, 1 received ipilimumab monotherapy prior to the closure of Arm C in Amendment 06 and 1 received an unplanned treatment; both were excluded from analysis. Analyses are presented for the remaining 168 treated participants.

Participant milestones

Participant milestones
Measure	N3 60 M Naive Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; Naive = Anti-CTLA4 Naive	N3 60M Prog Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M, W2 Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy	N1 60M + I3 90M, W4 Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy	N1 60M +I3 90M, WU Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy	N1 30M + I3 30M Non-BM Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M +I3 30M BM Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	I3 Monotherapy Treatment Group: I3 = Ipilimumab 3 mg/kg infusion. Participant was enrolled prior to the closure of this arm via amendment	Unplanned Treatment Unplanned treatment of nivolumab 1 mg/kg x 4 then nivolumab 3 mg/kg
Overall Study STARTED	41	44	11	10	6	25	11	10	10	1	1
Overall Study COMPLETED	0	0	0	0	0	1	0	0	0	0	0
Overall Study NOT COMPLETED	41	44	11	10	6	24	11	10	10	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	N3 60 M Naive Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; Naive = Anti-CTLA4 Naive	N3 60M Prog Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M, W2 Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy	N1 60M + I3 90M, W4 Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy	N1 60M +I3 90M, WU Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy	N1 30M + I3 30M Non-BM Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M +I3 30M BM Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	I3 Monotherapy Treatment Group: I3 = Ipilimumab 3 mg/kg infusion. Participant was enrolled prior to the closure of this arm via amendment	Unplanned Treatment Unplanned treatment of nivolumab 1 mg/kg x 4 then nivolumab 3 mg/kg
Overall Study Subject no longer meets study criteria	0	0	0	0	1	0	0	0	0	0	0
Overall Study Maximum clinical benefit	3	2	0	0	0	0	1	2	2	0	0
Overall Study Withdrawal by Subject	1	0	0	0	0	1	0	0	0	0	0
Overall Study Subject request to discontinue study	1	3	1	1	0	2	1	0	1	0	0
Overall Study Adverse event unrelated to study drug	1	1	0	0	0	0	0	2	0	0	0
Overall Study Disease progression	27	28	1	5	3	8	7	1	4	1	1
Overall Study Study drug toxicity	1	4	5	3	1	10	1	4	1	0	0
Overall Study Death	0	0	0	0	0	0	0	0	1	0	0
Overall Study Other reasons	7	6	4	1	1	3	1	1	1	0	0

Baseline Characteristics

PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N3 60 M Naive n=41 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; Naive = Anti-CTLA4 Naive	N3 60M Prog n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed;	N1 60M + I3 90M, W2 n=11 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy	N1 60M + I3 90M, W4 n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy	N1 60M +I3 90M, WU n=6 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M +I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	I3 Monotherapy n=1 Participants Treatment Group: I3 = Ipilimumab 3 mg/kg infusion. Participant was enrolled prior to the closure of this arm via amendment	Unplanned Treatment n=1 Participants Unplanned treatment of nivolumab 1 mg/kg x 4 then nivolumab 3 mg/kg	Total n=170 Participants Total of all reporting groups
Age, Continuous	55.5 Years STANDARD_DEVIATION 12.49 • n=5 Participants	53.7 Years STANDARD_DEVIATION 15.10 • n=7 Participants	61.0 Years STANDARD_DEVIATION 11.82 • n=5 Participants	58.5 Years STANDARD_DEVIATION 13.29 • n=4 Participants	56.8 Years STANDARD_DEVIATION 9.64 • n=21 Participants	56.9 Years STANDARD_DEVIATION 13.52 • n=10 Participants	51.5 Years STANDARD_DEVIATION 15.55 • n=115 Participants	56.9 Years STANDARD_DEVIATION 9.37 • n=6 Participants	58.9 Years STANDARD_DEVIATION 13.46 • n=6 Participants	52.0 Years STANDARD_DEVIATION NA • n=64 Participants	66.0 Years STANDARD_DEVIATION NA • n=17 Participants	55.9 Years STANDARD_DEVIATION 13.27 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=10 Participants	4 Participants n=115 Participants	4 Participants n=6 Participants	5 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	69 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	17 Participants n=10 Participants	7 Participants n=115 Participants	6 Participants n=6 Participants	5 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	101 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	6 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	41 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	15 Participants n=10 Participants	5 Participants n=115 Participants	3 Participants n=6 Participants	7 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants	128 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	10 Participants n=10 Participants	5 Participants n=115 Participants	6 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	36 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	43 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	6 Participants n=21 Participants	25 Participants n=10 Participants	11 Participants n=115 Participants	10 Participants n=6 Participants	10 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants	169 Participants n=21 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: From last non-missing value prior to first dose to week 7 day 1

Population: All response evaluable participants who were treated per the protocol

Baseline and post-treatment modulation of serum levels of chemokines, cytokines and other immune mediators were assessed by techniques that included ELISA or other multiplex-based assay methods. Primary analysis included IFN-gamma and IFN-gamma inducible factors, including chemokine \[C-X-C motif\] ligand 9 (CXCL9) and CXCL10

Outcome measures

Outcome measures
Measure	N3 60M Naive n=40 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=40 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=23 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=8 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=7 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=50 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=58 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=98 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=58 Participants Treatment Group: All Combination Therapy	Total n=156 Participants All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors IFN-gamma Simoa	0.0130 pg/mL Standard Deviation 0.1740	0.0320 pg/mL Standard Deviation 0.0817	0.2310 pg/mL Standard Deviation 0.4528	0.1600 pg/mL Standard Deviation 1.2047	0.0520 pg/mL Standard Deviation 0.1207	0.0950 pg/mL Standard Deviation 1.5082	0.0375 pg/mL Standard Deviation 0.1868	0.2200 pg/mL Standard Deviation 0.8198	0.0130 pg/mL Standard Deviation 0.1674	0.0240 pg/mL Standard Deviation 0.1373	0.1520 pg/mL Standard Deviation 1.0023	0.0515 pg/mL Standard Deviation 0.5944	—	—	—	—
Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors CXL9 (aka MIG)	1105.0 pg/mL Standard Deviation 10467.4	1890.0 pg/mL Standard Deviation 8706.0	4680.0 pg/mL Standard Deviation 18096.9	3542.0 pg/mL Standard Deviation 12133.1	-29.0 pg/mL Standard Deviation 1684.2	5692.0 pg/mL Standard Deviation 6796.0	3610.0 pg/mL Standard Deviation 2197.4	458.5 pg/mL Standard Deviation 1651.0	1056.5 pg/mL Standard Deviation 9167.8	1235.0 pg/mL Standard Deviation 8984.2	4680.0 pg/mL Standard Deviation 14792.5	2027.0 pg/mL Standard Deviation 11491.9	—	—	—	—
Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors CXL10 (aka IP10)	184.0 pg/mL Standard Deviation 514.1	160.0 pg/mL Standard Deviation 539.9	684.0 pg/mL Standard Deviation 2563.1	934.5 pg/mL Standard Deviation 2842.0	26.0 pg/mL Standard Deviation 172.7	514.0 pg/mL Standard Deviation 612.3	318.0 pg/mL Standard Deviation 354.0	695.0 pg/mL Standard Deviation 2627.7	185.0 pg/mL Standard Deviation 474.6	184.0 pg/mL Standard Deviation 500.7	684.0 pg/mL Standard Deviation 2450.6	234.5 pg/mL Standard Deviation 1566.3	—	—	—	—

PRIMARY outcome

Timeframe: From last non-missing value prior to first dose to week 4 day 1

Population: All response evaluable participants who were treated per the protocol

Outcome measures

Outcome measures
Measure	N3 60M Naive n=25 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=23 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=11 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=15 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=3 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=2 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=48 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=12 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=29 Participants Treatment Group: All Combination Therapy	Total n=26 Participants All treatments	Naive Nivo Mono Non-BM n=35 Participants Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM n=40 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent positive CD8 Week 2	—	—	11.345 Percentage of positive cells Standard Deviation 21.316	—	7.970 Percentage of positive cells Standard Deviation 15.132	10.100 Percentage of positive cells Standard Deviation 10.909	8.470 Percentage of positive cells Standard Deviation 7.740	29.735 Percentage of positive cells Standard Deviation 5.254	—	10.910 Percentage of positive cells Standard Deviation 12.387	9.080 Percentage of positive cells Standard Deviation 17.510	9.125 Percentage of positive cells Standard Deviation 18.654	10.100 Percentage of positive cells Standard Deviation 10.909	9.125 Percentage of positive cells Standard Deviation 18.654	—	—
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent positive CD4 Week 4	1.585 Percentage of positive cells Standard Deviation 3.071	1.260 Percentage of positive cells Standard Deviation 4.641	—	9.005 Percentage of positive cells Standard Deviation 13.324	24.520 Percentage of positive cells Standard Deviation 2.659	—	—	—	1.275 Percentage of positive cells Standard Deviation 3.921	—	24.520 Percentage of positive cells Standard Deviation 2.659	24.520 Percentage of positive cells Standard Deviation 2.659	1.585 Percentage of positive cells Standard Deviation 3.071	10.155 Percentage of positive cells Standard Deviation 12.707	—	—
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent CD4 Baseline	0.360 Percentage of positive cells Standard Deviation 1.844	0.600 Percentage of positive cells Standard Deviation 2.268	0.840 Percentage of positive cells Standard Deviation 1.852	0.470 Percentage of positive cells Standard Deviation 3.833	4.155 Percentage of positive cells Standard Deviation 6.624	4.950 Percentage of positive cells Standard Deviation 4.992	6.500 Percentage of positive cells Standard Deviation 8.108	2.780 Percentage of positive cells Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	0.375 Percentage of positive cells Standard Deviation 2.057	4.600 Percentage of positive cells Standard Deviation 4.807	2.750 Percentage of positive cells Standard Deviation 5.833	2.610 Percentage of positive cells Standard Deviation 5.607	0.870 Percentage of positive cells Standard Deviation 3.727	1.510 Percentage of positive cells Standard Deviation 6.023	—	—
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent positive CD4 Week 2	—	—	4.500 Percentage of positive cells Standard Deviation 10.741	—	6.260 Percentage of positive cells Standard Deviation 8.518	4.210 Percentage of positive cells Standard Deviation 5.029	6.420 Percentage of positive cells Standard Deviation 14.778	20.830 Percentage of positive cells Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	—	6.155 Percentage of positive cells Standard Deviation 6.585	6.125 Percentage of positive cells Standard Deviation 10.222	5.990 Percentage of positive cells Standard Deviation 9.602	4.210 Percentage of positive cells Standard Deviation 5.029	5.990 Percentage of positive cells Standard Deviation 9.602	—	—
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent CD8 Baseline	3.730 Percentage of positive cells Standard Deviation 10.994	7.230 Percentage of positive cells Standard Deviation 10.712	3.260 Percentage of positive cells Standard Deviation 9.259	11.105 Percentage of positive cells Standard Deviation 9.524	4.700 Percentage of positive cells Standard Deviation 9.810	5.615 Percentage of positive cells Standard Deviation 12.475	18.590 Percentage of positive cells Standard Deviation 8.132	6.135 Percentage of positive cells Standard Deviation 5.664	6.360 Percentage of positive cells Standard Deviation 10.727	5.615 Percentage of positive cells Standard Deviation 11.472	4.700 Percentage of positive cells Standard Deviation 9.292	4.230 Percentage of positive cells Standard Deviation 9.401	5.210 Percentage of positive cells Standard Deviation 11.288	4.230 Percentage of positive cells Standard Deviation 9.844	—	—
Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay Percent positive CD8 Week 4	18.435 Percentage of positive cells Standard Deviation 17.108	7.140 Percentage of positive cells Standard Deviation 25.204	—	32.455 Percentage of positive cells Standard Deviation 15.967	37.465 Percentage of positive cells Standard Deviation 5.706	—	—	—	15.150 Percentage of positive cells Standard Deviation 21.475	—	37.465 Percentage of positive cells Standard Deviation 5.706	37.465 Percentage of positive cells Standard Deviation 5.706	18.435 Percentage of positive cells Standard Deviation 17.108	34.785 Percentage of positive cells Standard Deviation 13.856	—	—

SECONDARY outcome

Timeframe: Includes events reported between first dose and up to 100 days after last dose of study medication (up to approximately 73 months).

Population: All participants who received treatment per the protocol

The assessment of safety was based on frequency of deaths and adverse events (AEs). AEs were graded for severity according to the NCI CTCAE version 4.0.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Frequency of Adverse Events or Death Participants who died	26 Participants	25 Participants	11 Participants	14 Participants	4 Participants	2 Participants	4 Participants	—	—	—	—	—	—	—	—	—
Frequency of Adverse Events or Death Participants who died within 30 days of last dose	3 Participants	2 Participants	4 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—
Frequency of Adverse Events or Death Participants who died within 100 days of last dose	5 Participants	8 Participants	5 Participants	0 Participants	1 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—	—
Frequency of Adverse Events or Death Participants with an AE	41 Participants	44 Participants	27 Participants	25 Participants	11 Participants	10 Participants	10 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From enrollment to 100 days after the last dose date (up to approximately 73 months)

Population: All participants who received treatment per the protocol

The assessment of safety was based on frequency of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of study drug. AEs were graded for severity according to the NCI CTCAE version 4.0.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Frequency of AEs Leading to Discontinuation of Study Drug and SAEs SAEs	20 Participants	22 Participants	20 Participants	14 Participants	2 Participants	7 Participants	4 Participants	—	—	—	—	—	—	—	—	—
Frequency of AEs Leading to Discontinuation of Study Drug and SAEs AEs Leading to Discontinuation	2 Participants	6 Participants	12 Participants	9 Participants	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 101-120 days after last dose.

Population: Participants who were treated per the protocol and who had at least one on-treatment measurement of the corresponding laboratory parameter

Abnormalities in hepatic parameters measured included those in aspartate aminotransferase (AST), alanine aminotransferase (ALT)and total bilirubin, with respect to upper limit of normal (ULN)

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Number of Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAY	0 Events	0 Events	2 Events	1 Events	1 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 3XULN	2 Events	4 Events	8 Events	5 Events	3 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests ALT OR AST> 5XULN	1 Events	2 Events	6 Events	4 Events	1 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests ALT OR AST> 10XULN	1 Events	0 Events	3 Events	2 Events	1 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 20XULN	0 Events	0 Events	1 Events	0 Events	1 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests TOTAL BILIRUBIN > 2XULN	0 Events	0 Events	2 Events	1 Events	2 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	0 Events	0 Events	2 Events	1 Events	1 Events	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 101-120 days after last dose.

Population: Participants who were treated per the protocol and who had at least one on-treatment measurement of TSH

Abnormalities in thyroid parameters measured included those in thyroid stimulating hormone (TSH) levels with respect to upper limit of normal (ULN) and lower limit of normal (LLN)

Outcome measures

Outcome measures
Measure	N3 60M Naive n=29 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=33 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=21 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=8 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	0 Events	0 Events	3 Events	1 Events	0 Events	0 Events	1 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN	9 Events	16 Events	7 Events	7 Events	1 Events	3 Events	4 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN WITH TSH <= ULN AT BASELINE	4 Events	9 Events	7 Events	4 Events	1 Events	3 Events	2 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	0 Events	0 Events	3 Events	3 Events	0 Events	2 Events	2 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	0 Events	0 Events	0 Events	0 Events	0 Events	0 Events	0 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN WITH FT3/FT4 TEST MISSING	9 Events	16 Events	4 Events	4 Events	1 Events	1 Events	2 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH < LLN	3 Events	4 Events	11 Events	12 Events	2 Events	6 Events	5 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH TSH >= LLN AT BASELINE	3 Events	4 Events	11 Events	12 Events	2 Events	6 Events	5 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	0 Events	0 Events	5 Events	4 Events	0 Events	2 Events	2 Events	—	—	—	—	—	—	—	—	—
Number of Laboratory Abnormalities in Specific Thyroid Tests TSH < LLN WITH FT3/FT4 TEST MISSING	3 Events	4 Events	3 Events	7 Events	2 Events	4 Events	2 Events	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Approximately every 8 weeks until disease progression and in follow-up if no progression (up to approximately 73 months)

Population: All participants who received treatment per the protocol

The objective response rate (ORR) was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants in the population of interest. The BOR was defined as the participant's best response designation, over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per RECIST 1.1, with subsequent confirmation, or date of subsequent anti-cancer therapy, whichever occurred first in the study.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Objective Response Rate (ORR)	31.7 Percentage of participants Interval 18.1 to 48.1	22.7 Percentage of participants Interval 11.5 to 37.8	44.4 Percentage of participants Interval 25.5 to 64.7	40.0 Percentage of participants Interval 21.1 to 61.3	27.3 Percentage of participants Interval 6.0 to 61.0	70.0 Percentage of participants Interval 34.8 to 93.3	60.0 Percentage of participants Interval 26.2 to 87.8	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of first documented objective response to date of disease progression or death, up to approximately 27 months

Population: All participants who received treatment per the protocol

Median duration of response (mDOR) was calculated for subjects with BOR of CR or PR only, and is defined as time between the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Median Duration of Response (mDOR)	16.59 Months Interval 7.29 to Upper limit not reached due to insufficient number of events	NA Months Interval 5.55 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 5.85 to Median and upper limit not reached due to insufficient number of events	26.25 Months Interval 7.85 to Upper limit not reached due to insufficient number of events	NA Months Interval 3.71 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 22.01 to Median and upper limit not reached due to insufficient number of events	20.27 Months Interval 13.57 to Upper limit not reached due to insufficient number of events	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the first dosing date to the date of the first documented objective response, up to approximately 15 months

Population: All participants who received treatment per the protocol

Median time to response (mTTR) for a participant with a BOR of CR or PR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR).

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Median Time to Response (mTTR)	1.87 Months Interval 1.77 to 3.71	2.78 Months Interval 1.84 to 14.59	1.41 Months Interval 1.28 to 1.87	2.51 Months Interval 1.28 to 2.86	1.41 Months Interval 1.41 to 6.9	1.71 Months Interval 1.38 to 7.43	2.14 Months Interval 1.25 to 4.99	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study medication to the date of progression or death, whichever occurs first, up to approximately 29 months

Population: All participants who received treatment per the protocol

Progression free survival (PFS) for a participant was defined as the time from the date of first dose of study medication to the date of the first documented disease progression, or death due to any cause, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono Nivolumab Monotherapy CTLA-4 Naive	All Nivo Treatment Group: All Nivolumab Monotherapy	All Combo Treatment Group: All Combination Therapy	Total All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Progression Free Survival (PFS)	3.68 Months Interval 1.84 to 7.36	5.62 Months Interval 1.87 to 9.66	7.00 Months Interval 1.41 to Upper limit not reached due to insufficient number of events	9.69 Months Interval 1.94 to 29.01	4.93 Months Interval 1.41 to Upper limit not reached due to insufficient number of events	NA Months Interval 1.18 to Median and upper limit not reached due to insufficient number of events	23.00 Months Interval 0.85 to Upper limit not reached due to insufficient number of events	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to follow-up visit 2 (101-120 days since last treatment)

Population: A subset of all participants who were treated per the protocol who had a baseline and at least 1 post-baseline ADA assessment for nivolumab and ipilimumab separately

Time Frame: Part 1: Day 1, Day 15, Day 43 of cycle 1, Day 1 of cycle 2, Day 15 of cycle 3, every 16 weeks after cycle 3 up to 2 years, follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment) Part 2, 3 and 4: Weeks 1, 3, 4, 7, 9, 10, 13, 25, 53, 79, 95 follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment)

Outcome measures

Outcome measures
Measure	N3 60M Naive n=38 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=42 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=22 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=22 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=24 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=23 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=10 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=9 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=7 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=154 Participants Treatment Group: All Combination Therapy	Total n=54 Participants All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Immunogenicity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Number of Serum Anti-drug Antibody (ADA) Positive Participants and the Number of Neutralizing ADA Positive Participants ADA positive	2 Participants	5 Participants	10 Participants	1 Participants	16 Participants	4 Participants	1 Participants	7 Participants	0 Participants	1 Participants	42 Participants	5 Participants	—	—	—	—
Immunogenicity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Number of Serum Anti-drug Antibody (ADA) Positive Participants and the Number of Neutralizing ADA Positive Participants Neutralizing ADA positive	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	—	0 Participants	3 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Approximately every 8 weeks until disease progression and in follow-up if no progression (up to approximately 73 months)

Population: All participants who received treatment per the protocol

For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels \>= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. The objective response rate (ORR) was defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects in the population of interest (all response-evaluable participants).

Outcome measures

Outcome measures
Measure	N3 60M Naive n=39 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=36 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=11 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=6 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=22 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=9 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=4 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=3 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=75 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=12 Participants Treatment Group: All Combination Therapy	Total n=37 Participants All treatments	Naive Nivo Mono Non-BM n=33 Participants Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM n=48 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM n=49 Participants N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total n=140 Participants All treatments
Objective Response Rate (ORR) by PD-L1 Expression STTU 1 - 1% Level PD-L1 Status: Met criteria	40.0 Percentage of Participants Interval 19.1 to 63.9	35.3 Percentage of Participants Interval 14.2 to 61.7	85.7 Percentage of Participants Interval 42.1 to 99.6	50.0 Percentage of Participants Interval 11.8 to 88.2	50.0 Percentage of Participants Interval 1.3 to 98.7	63.6 Percentage of Participants Interval 30.8 to 89.1	40.0 Percentage of Participants Interval 5.3 to 85.3	100.0 Percentage of Participants Interval 15.8 to 100.0	100.0 Percentage of Participants Interval 2.5 to 100.0	37.8 Percentage of Participants Interval 22.5 to 55.2	50.0 Percentage of Participants Interval 11.8 to 88.2	75.0 Percentage of Participants Interval 50.9 to 91.3	72.2 Percentage of Participants Interval 46.5 to 90.3	40.0 Percentage of Participants Interval 21.1 to 61.3	65.4 Percentage of Participants Interval 44.3 to 82.8	50.7 Percentage of Participants Interval 38.6 to 62.8
Objective Response Rate (ORR) by PD-L1 Expression STTU 1 - 10% Level PD-L1 Status: Met criteria	42.9 Percentage of Participants Interval 9.9 to 81.6	20.0 Percentage of Participants Interval 0.5 to 71.6	100.0 Percentage of Participants Interval 29.2 to 100.0	75.0 Percentage of Participants Interval 19.4 to 99.4	100.0 Percentage of Participants Interval 2.5 to 100.0	66.7 Percentage of Participants Interval 9.4 to 99.2	100.0 Percentage of Participants Interval 2.5 to 100.0	100.0 Percentage of Participants Interval 15.8 to 100.0	100.0 Percentage of Participants Interval 2.5 to 100.0	33.3 Percentage of Participants Interval 9.9 to 65.1	100.0 Percentage of Participants Interval 15.8 to 100.0	87.5 Percentage of Participants Interval 47.3 to 99.7	83.3 Percentage of Participants Interval 35.9 to 99.6	50.0 Percentage of Participants Interval 15.7 to 84.3	81.8 Percentage of Participants Interval 48.2 to 97.7	63.0 Percentage of Participants Interval 42.4 to 80.6
Objective Response Rate (ORR) by PD-L1 Expression STTU 1 - 5% Level PD-L1 Status: Met criteria	40.0 Percentage of Participants Interval 12.2 to 73.8	33.3 Percentage of Participants Interval 7.5 to 70.1	80.0 Percentage of Participants Interval 28.4 to 99.5	60.0 Percentage of Participants Interval 14.7 to 94.7	100.0 Percentage of Participants Interval 2.5 to 100.0	71.4 Percentage of Participants Interval 29.0 to 96.3	50.0 Percentage of Participants Interval 1.3 to 98.7	100.0 Percentage of Participants Interval 15.8 to 100.0	100.0 Percentage of Participants Interval 2.5 to 100.0	36.8 Percentage of Participants Interval 16.3 to 61.6	66.7 Percentage of Participants Interval 9.4 to 99.2	78.6 Percentage of Participants Interval 49.2 to 95.3	75.0 Percentage of Participants Interval 42.8 to 94.5	41.7 Percentage of Participants Interval 15.2 to 72.3	72.2 Percentage of Participants Interval 46.5 to 90.3	57.1 Percentage of Participants Interval 41.0 to 72.3

SECONDARY outcome

Timeframe: From the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, up to approximately 73 months

Population: All response evaluable participants who were treated per the protocol

For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels \>= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. Median duration of response (mDOR) was calculated for all response-evaluable participants with best overall response of CR or PR only, and is defined as time between the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=39 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=36 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=11 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=6 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=22 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=9 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=4 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=3 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=75 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=12 Participants Treatment Group: All Combination Therapy	Total n=37 Participants All treatments	Naive Nivo Mono Non-BM n=33 Participants Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM n=48 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM n=49 Participants N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total n=140 Participants All treatments
Duration of Response (DOR) by PD-L1 Expression STTU 1 - 5% Level PD-L1 Status: Met criteria	15.21 Months Interval 11.5 to 16.59	NA Months Interval 15.57 to Median and upper limit not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limit not reached due to insufficient number of events.	NA Months Median, lower limit and upper limit not reached due to insufficient number of events.	NA Months Median, lower limit and upper limit not reached due to insufficient number of events.	26.25 Months Interval 8.31 to Upper limit not reached due to insufficient number of events.	NA Months Interval 3.71 to Median and upper limits not reached due to insufficient number of events.	22.01 Months Lower and upper limits not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	16.59 Months Interval 11.5 to Upper limit not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	26.25 Months Interval 8.31 to Upper limit not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limits not reached due to insufficient number of events.	16.59 Months Interval 11.5 to Upper limit not reached due to insufficient number of events.	NA Months Interval 8.31 to Median and upper limits not reached due to insufficient number of events.	26.25 Months Interval 15.57 to Upper limit not reached due to insufficient number of events.
Duration of Response (DOR) by PD-L1 Expression STTU 1 - 10% Level PD-L1 Status: Met criteria	15.90 Months Interval 15.21 to 16.59	15.57 Months Lower and upper limits not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limit not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	22.01 Months Lower and upper limits not reached due to insufficient number of events.	NA Months Median, lower and upper limits not reached due to insufficient number of events.	15.57 Months Interval 15.21 to 16.59	NA Months Median, lower and upper limits not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limits not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limits not reached due to insufficient number of events.	16.59 Months Interval 15.21 to Upper limit not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limits not reached due to insufficient number of events.	NA Months Interval 15.57 to Median and upper limits not reached due to insufficient number of events.
Duration of Response (DOR) by PD-L1 Expression STTU 1 - 1% Level PD-L1 Status: Met criteria	15.21 Months Interval 4.6 to 18.2	NA Months Interval 15.57 to Median and upper limit not reached due to insufficient number of events.	NA Months Interval 2.96 to Median and upper limit not reached due to insufficient number of events.	NA Months Median, lower limit and upper limit not reached due to insufficient number of events.	NA Months Median, lower limit and upper limit not reached due to insufficient number of events.	26.25 Months Interval 8.31 to Upper limit not reached due to insufficient number of events.	NA Months Interval 3.71 to Median and upper limit not reached due to insufficient number of events.	22.01 Months Upper and lower limits not reached due to insufficient number of events.	NA Months Median, upper and lower limits not reached due to insufficient number of events.	16.59 Months Interval 11.5 to Upper limit not reached due to insufficient number of events.	NA Months Interval 3.71 to Median and upper limit not reached due to insufficient number of events.	26.25 Months Interval 22.01 to Upper limit not reached due to insufficient number of events.	NA Months Interval 8.31 to Median and upper limit not reached due to insufficient number of events.	15.21 Months Interval 3.71 to Upper limit not reached due to insufficient number of events.	NA Months Interval 26.25 to Median and upper limit not reached due to insufficient number of events.	26.25 Months Interval 16.59 to Upper limit not reached due to insufficient number of events.

SECONDARY outcome

Timeframe: From first dose of study medication to the date of progression or death, whichever occurs first, up to approximately 29 months

Population: All response evaluable participants who were treated per the protocol

For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels \>= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. The progression free survival rate (PFSR) for a subject was defined as the time from the date of first dose of study medication to the date of the first documented disease progression, or death due to any cause, whichever occurred first, if death occurred within 100 days after last dose of study medication.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=39 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=36 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=11 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=6 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=22 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=9 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=4 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=3 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=75 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=12 Participants Treatment Group: All Combination Therapy	Total n=37 Participants All treatments	Naive Nivo Mono Non-BM n=33 Participants Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM n=48 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM n=49 Participants N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total n=140 Participants All treatments
Progression Free Survival (PFS) by PD-L1 Expression STTU 1 - 5% Level PD-L1 Status: Met criteria	6.28 Months Interval 0.33 to 17.05	19.29 Months Interval 1.77 to Upper limit not reached due to insufficient number of events	NA Months Interval 1.22 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 0.85 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	29.01 Months Interval 1.94 to 29.01	NA Months Interval 1.22 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 23.95 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	7.20 Months Interval 1.87 to 18.4	NA Months Interval 1.22 to Median and upper limit not reached due to insufficient number of events	29.01 Months Interval 3.02 to Upper limit not reached due to insufficient number of events	29.01 Months Interval 1.94 to Upper limit not reached due to insufficient number of events	6.28 Months Interval 1.22 to 17.05	29.01 Months Interval 3.02 to Upper limit not reached due to insufficient number of events	17.05 Months Interval 5.36 to 29.01
Progression Free Survival (PFS) by PD-L1 Expression STTU 1 - 10% Level PD-L1 Status: Met criteria	5.36 Months Interval 0.33 to 18.4	19.29 Months Interval 1.77 to 19.29	NA Months Interval 4.17 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 1.64 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	NA Months Interval 1.94 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	NA Months Interval 23.95 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	6.24 Months Interval 1.71 to 18.4	NA Months Median, lower and upper limit not reached due to insufficient number of events	NA Months Interval 1.94 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 1.94 to Median and upper limit not reached due to insufficient number of events	11.20 Months Interval 0.33 to Upper limit not reached due to insufficient number of events	NA Months Interval 1.94 to Median and upper limit not reached due to insufficient number of events	19.29 Months Interval 5.36 to Upper limit not reached due to insufficient number of events
Progression Free Survival (PFS) by PD-L1 Expression STTU 1 - 1% Level PD-L1 Status: Met criteria	4.50 Months Interval 1.84 to 15.18	9.66 Months Interval 3.71 to Upper limit not reached due to insufficient number of events	NA Months Interval 1.22 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 0.85 to Median and upper limit not reached due to insufficient number of events	NA Months Interval 0.76 to Median and upper limit not reached due to insufficient number of events	29.01 Months Interval 1.94 to 29.01	8.77 Months Interval 1.22 to Upper limit not reached due to insufficient number of events	NA Months Interval 23.95 to Median and upper limit not reached due to insufficient number of events	NA Months Median, lower and upper limit not reached due to insufficient number of events	6.24 Months Interval 3.65 to 17.05	8.77 Months Interval 1.22 to Upper limit not reached due to insufficient number of events	29.01 Months Interval 4.17 to Upper limit not reached due to insufficient number of events	29.01 Months Interval 3.02 to Upper limit not reached due to insufficient number of events	5.36 Months Interval 1.94 to 10.94	29.01 Months Interval 3.02 to Upper limit not reached due to insufficient number of events	10.58 Months Interval 5.62 to 19.81

SECONDARY outcome

Timeframe: From first dose of study medication to the date of death for any cause, up to approximately 73 months

Population: All participants who were treated per the protocol

The percentage of participants surviving to time t, where t is a specific length of time, eg, 12 months, which was determined by the available data for final analysis and was documented in the DPP. The percentage was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data. The overall survival rate (OSR) for a participant was defined as the time from the date of first dose of study medication to the date of death for any cause. A participant who had not died was censored at last known date alive.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=52 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=62 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=106 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=62 Participants Treatment Group: All Combination Therapy	Total n=168 Participants All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Overall Survival Rate (OSR) 12 months	72.4 Percentage of participants Interval 55.7 to 83.7	64.5 Percentage of participants Interval 48.2 to 76.9	77.6 Percentage of participants Interval 56.8 to 89.3	88.0 Percentage of participants Interval 67.3 to 96.0	80.0 Percentage of participants Interval 40.9 to 94.6	90.0 Percentage of participants Interval 47.3 to 98.5	68.6 Percentage of participants Interval 30.5 to 88.7	82.6 Percentage of participants Interval 69.3 to 90.6	73.1 Percentage of participants Interval 59.8 to 82.6	69.5 Percentage of participants Interval 59.5 to 77.5	83.8 Percentage of participants Interval 72.0 to 91.0	74.9 Percentage of participants Interval 67.5 to 80.9	—	—	—	—
Overall Survival Rate (OSR) 24 months	51.0 Percentage of participants Interval 34.3 to 65.4	46.8 Percentage of participants Interval 31.1 to 61.1	69.6 Percentage of participants Interval 48.3 to 83.5	58.1 Percentage of participants Interval 36.0 to 75.0	58.3 Percentage of participants Interval 23.0 to 82.1	80.0 Percentage of participants Interval 40.9 to 94.6	57.1 Percentage of participants Interval 21.7 to 81.5	64.3 Percentage of participants Interval 49.3 to 75.8	53.3 Percentage of participants Interval 39.6 to 65.2	50.6 Percentage of participants Interval 40.3 to 60.0	66.8 Percentage of participants Interval 53.3 to 77.2	56.8 Percentage of participants Interval 48.7 to 64.1	—	—	—	—
Overall Survival Rate (OSR) 3 months	92.7 Percentage of participants Interval 79.0 to 97.6	90.8 Percentage of participants Interval 77.3 to 96.4	85.2 Percentage of participants Interval 65.2 to 94.2	100.0 Percentage of participants Interval 100.0 to 100.0	90.0 Percentage of participants Interval 47.3 to 98.5	90.0 Percentage of participants Interval 47.3 to 98.5	80.0 Percentage of participants Interval 40.9 to 94.6	92.3 Percentage of participants Interval 80.8 to 97.0	90.2 Percentage of participants Interval 79.6 to 95.5	90.5 Percentage of participants Interval 83.0 to 94.8	91.9 Percentage of participants Interval 81.7 to 96.6	91.0 Percentage of participants Interval 85.5 to 94.5	—	—	—	—
Overall Survival Rate (OSR) 6 months	85.3 Percentage of participants Interval 70.2 to 93.1	78.9 Percentage of participants Interval 63.3 to 88.4	81.5 Percentage of participants Interval 61.1 to 91.8	100.0 Percentage of participants Interval 100.0 to 100.0	90.0 Percentage of participants Interval 47.3 to 98.5	90.0 Percentage of participants Interval 47.3 to 98.5	80.0 Percentage of participants Interval 40.9 to 94.6	90.4 Percentage of participants Interval 78.4 to 95.9	85.3 Percentage of participants Interval 73.6 to 92.0	82.6 Percentage of participants Interval 73.8 to 88.6	90.3 Percentage of participants Interval 79.7 to 95.5	85.5 Percentage of participants Interval 79.2 to 90.1	—	—	—	—
Overall Survival Rate (OSR) 9 months	75.0 Percentage of participants Interval 58.5 to 85.7	71.7 Percentage of participants Interval 55.5 to 82.8	81.5 Percentage of participants Interval 61.1 to 91.8	88.0 Percentage of participants Interval 67.3 to 96.0	90.0 Percentage of participants Interval 47.3 to 98.5	90.0 Percentage of participants Interval 47.3 to 98.5	68.6 Percentage of participants Interval 30.5 to 88.7	84.6 Percentage of participants Interval 71.6 to 92.0	76.6 Percentage of participants Interval 63.7 to 85.4	74.6 Percentage of participants Interval 64.9 to 81.9	85.5 Percentage of participants Interval 74.0 to 92.2	78.7 Percentage of participants Interval 71.6 to 84.2	—	—	—	—

SECONDARY outcome

Timeframe: From first dose up to the specified timepoints of 3, 6, 9, 12, and 24 months

Population: All participants treated per the protocol

The Progression Free Survival Rate (PFSR) is defined as the probability of a participant remaining progression free or survival to time t, where t is equal to the specified timepoints. This probability will be calculated by the product limit method (Kaplan-Meier estimates) which takes into account censored data. Medians and 95% confidence interval are estimated using the Kaplan-Meier method. If there is an insufficient number of events, the median and confidence intervals cannot be calculated.

Outcome measures

Outcome measures
Measure	N3 60M Naive n=41 Participants Treatment Group: Part 1: Nivolumab 3 mg/kg 60 Minute Infusion Anti-CTLA4 Naive	N3 60M PROG n=44 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M n=27 Participants Treatment Group: Part 2: Nivolumab 1 mg/kg 60 Minute Infusion + Ipilimumab 3 mg/kg 90 Minute	N1 30M + I3 30M Non-BM n=25 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 Participants Treatment Group: N3 = Nivolumab 3mg/kg;30M = 30 minute infusion; BM = Brain metastases	N1 30M + I3 30M BM n=10 Participants Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 Participants Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N1+ I3 Non-BM n=52 Participants Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	Naive Nivo Mono n=62 Participants Nivolumab Monotherapy CTLA-4 Naive	All Nivo n=106 Participants Treatment Group: All Nivolumab Monotherapy	All Combo n=62 Participants Treatment Group: All Combination Therapy	Total n=168 Participants All treatments	Naive Nivo Mono Non-BM Treatment Group: Naive Nivolumab Mono Non-Brain Metastases	N1 + I3 Non-BM Treatment Group: Part 2+3: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg Non-Brain Metastases	N1 + I3 NON-BM N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; BM = Brain metastases	Total All treatments
Percent Probability for Progression Free Survival Rate (PFSR) 6 months	38.7 Percent probability Interval 24.0 to 53.2	47.1 Percent probability Interval 31.8 to 61.0	50.7 Percent probability Interval 30.6 to 67.7	60.1 Percent probability Interval 37.2 to 76.9	NA Percent probability The median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	77.8 Percent probability Interval 36.5 to 93.9	70.0 Percent probability Interval 32.9 to 89.2	55.0 Percent probability Interval 40.0 to 67.6	44.3 Percent probability Interval 31.5 to 56.3	45.4 Percent probability Interval 35.6 to 54.7	58.2 Percent probability Interval 44.3 to 69.7	49.8 Percent probability Interval 41.8 to 57.3	—	—	—	—
Percent Probability for Progression Free Survival Rate (PFSR) 3 months	53.7 Percent probability Interval 37.4 to 67.4	59.1 Percent probability Interval 43.2 to 71.9	54.6 Percent probability Interval 34.0 to 71.2	69.3 Percent probability Interval 46.1 to 84.0	54.5 Percent probability Interval 22.9 to 78.0	77.8 Percent probability Interval 36.5 to 93.9	70.0 Percent probability Interval 32.9 to 89.2	61.3 Percent probability Interval 46.2 to 73.3	56.5 Percent probability Interval 43.3 to 67.7	57.5 Percent probability Interval 47.6 to 66.3	63.6 Percent probability Interval 49.8 to 74.6	59.5 Percent probability Interval 51.5 to 66.6	—	—	—	—
Percent Probability for Progression Free Survival Rate (PFSR) 9 months	33.2 Percent probability Interval 19.3 to 47.8	42.2 Percent probability Interval 27.3 to 56.3	42.2 Percent probability Interval 23.2 to 60.2	55.0 Percent probability Interval 37.2 to 76.9	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	77.8 Percent probability Interval 36.5 to 93.9	70.0 Percent probability Interval 32.9 to 89.2	48.0 Percent probability Interval 33.2 to 61.3	38.5 Percent probability Interval 26.1 to 50.7	40.0 Percent probability Interval 30.4 to 49.4	52.3 Percent probability Interval 38.5 to 64.4	44.2 Percent probability Interval 36.3 to 51.8	—	—	—	—
Percent Probability for Progression Free Survival Rate (PFSR) 12 months	30.4 Percent probability Interval 17.0 to 45.0	34.3 Percent probability Interval 20.4 to 48.6	42.2 Percent probability Interval 23.2 to 60.2	36.7 Percent probability Interval 16.2 to 57.6	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	77.8 Percent probability Interval 36.5 to 93.9	70.0 Percent probability Interval 32.9 to 89.2	40.1 Percent probability Interval 25.8 to 54.0	34.7 Percent probability Interval 22.7 to 46.9	34.4 Percent probability Interval 25.2 to 43.8	45.8 Percent probability Interval 32.1 to 58.5	38.3 Percent probability Interval 30.6 to 46.0	—	—	—	—
Percent Probability for Progression Free Survival Rate (PFSR) 24 months	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	21.8 Percent probability Interval 10.2 to 36.2	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	40.1 Percent probability Interval 25.8 to 54.0	NA Percent probability Median, the lower limit, and the upper limit were not calculated because there was an insufficient number of events to calculate using the Kaplan-Meier method.	18.2 Percent probability Interval 10.7 to 27.3	42.3 Percent probability Interval 28.2 to 55.7	26.5 Percent probability Interval 19.2 to 34.3	—	—	—	—

Adverse Events

N3 60M NAIVE

Serious events: 20 serious events

Other events: 41 other events

Deaths: 26 deaths

N3 60M PROG

Serious events: 22 serious events

Other events: 44 other events

Deaths: 25 deaths

N1 60M + I3 90M, W2

Serious events: 8 serious events

Other events: 11 other events

Deaths: 4 deaths

N1 60M + I3 90M, W4

Serious events: 6 serious events

Other events: 10 other events

Deaths: 3 deaths

N1 60M + I3 90M, WU

Serious events: 6 serious events

Other events: 6 other events

Deaths: 4 deaths

N1 30M + I3 30M Non-BM

Serious events: 14 serious events

Other events: 25 other events

Deaths: 14 deaths

N3 30M Non-BM

Serious events: 2 serious events

Other events: 10 other events

Deaths: 4 deaths

I3 Monotherapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

N1 30M + I3 30M BM

Serious events: 7 serious events

Other events: 10 other events

Deaths: 2 deaths

N3 30M BM

Serious events: 4 serious events

Other events: 9 other events

Deaths: 4 deaths

Unplanned Treatment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	N3 60M NAIVE n=41 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; Naive = Anti-CTLA4 Naive	N3 60M PROG n=44 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M, W2 n=11 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy	N1 60M + I3 90M, W4 n=10 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy	N1 60M + I3 90M, WU n=6 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy	N1 30M + I3 30M Non-BM n=25 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	I3 Monotherapy n=1 participants at risk Treatment Group: I3 = Ipilimumab 3 mg/kg infusion. Participant was enrolled prior to the closure of this arm via amendment	N1 30M + I3 30M BM n=10 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	Unplanned Treatment n=1 participants at risk Unplanned treatment of nivolumab 1 mg/kg x 4 then nivolumab 3 mg/kg
Renal and urinary disorders Acute kidney injury	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Aphasia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Arachnoiditis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dizziness	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dysaesthesia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Guillain-Barre syndrome	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Hemiparesis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Monoplegia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Nervous system disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Nystagmus	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Paraesthesia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Seizure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Haematuria	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Renal failure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Reproductive system and breast disorders Pelvic pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Enterocolitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Anaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Thrombocytopenia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Acute myocardial infarction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Atrial fibrillation	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Cardiac failure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Cardiac failure congestive	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Myocardial infarction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Adrenal insufficiency	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Hyperthyroidism	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Hypophysitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Iridocyclitis	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Autoimmune colitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Colitis	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Constipation	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Diarrhoea	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Necrotising oesophagitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Pancreatitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Small intestinal obstruction	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Volvulus	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Vomiting	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Fatigue	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Malaise	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Non-cardiac chest pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Pyrexia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Hepatitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Hepatotoxicity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Liver disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Immune system disorders Hypersensitivity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Clostridium difficile infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Encephalitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Liver abscess	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Meningitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Pneumonia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Respiratory tract infection	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Sepsis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Sinusitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Staphylococcal infection	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Urinary tract infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Brain herniation	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Alanine aminotransferase increased	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Aspartate aminotransferase increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood alkaline phosphatase increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood bilirubin increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Hepatic enzyme increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Lipase increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Failure to thrive	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyperkalaemia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyponatraemia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Flank pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 8/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Hypotension	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Nausea	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Fall	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Confusional state	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Mental status changes	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).

Other adverse events

Other adverse events
Measure	N3 60M NAIVE n=41 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; Naive = Anti-CTLA4 Naive	N3 60M PROG n=44 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 60M = 60 minute infusion; PROG = Anti-CTLA4 Progressed	N1 60M + I3 90M, W2 n=11 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W2 = Week 2 Biopsy	N1 60M + I3 90M, W4 n=10 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; W4 = Week 4 Biopsy	N1 60M + I3 90M, WU n=6 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 90M = 90 minute infusion; 60M = 60 minute infusion; WU = Unknown Week Biopsy	N1 30M + I3 30M Non-BM n=25 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M Non-BM n=11 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	I3 Monotherapy n=1 participants at risk Treatment Group: I3 = Ipilimumab 3 mg/kg infusion. Participant was enrolled prior to the closure of this arm via amendment	N1 30M + I3 30M BM n=10 participants at risk Treatment Group: N1 = Nivolumab 1mg/kg; I3 = Ipilimumab 3 mg/kg; 30M = 30 minute infusion; BM = Brain metastases	N3 30M BM n=10 participants at risk Treatment Group: N3 = Nivolumab 3mg/kg; 30M = 30 minute infusion; BM = Brain metastases	Unplanned Treatment n=1 participants at risk Unplanned treatment of nivolumab 1 mg/kg x 4 then nivolumab 3 mg/kg
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Productive cough	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Laryngitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Onychomycosis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Oral candidiasis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Dry mouth	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	13.6% 6/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Cellulitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Anaemia	22.0% 9/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 8/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 5/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Thrombocytopenia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Acute coronary syndrome	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Angina pectoris	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Palpitations	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Tachycardia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Ear and labyrinth disorders Hypoacusis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Adrenal insufficiency	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Endocrine disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Hyperthyroidism	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Hypophysitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Hypothyroidism	12.2% 5/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 5/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Endocrine disorders Thyroiditis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Dry eye	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Eye disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Eye pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Uveitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Vision blurred	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Visual impairment	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal distension	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal pain	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal pain upper	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Anal pruritus	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Colitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Constipation	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	31.8% 14/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.4% 4/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Diarrhoea	36.6% 15/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	31.8% 14/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	45.5% 5/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 5/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.0% 9/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.4% 4/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	60.0% 6/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Dyspepsia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Dysphagia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Flatulence	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Gastritis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Haemorrhoids	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Nausea	22.0% 9/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 12/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	52.0% 13/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.4% 4/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	70.0% 7/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Oral pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Stomatitis	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Vomiting	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.0% 9/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Asthenia	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Chest pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Chills	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Fatigue	51.2% 21/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	65.9% 29/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	63.6% 7/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	66.7% 4/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	52.0% 13/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	45.5% 5/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	60.0% 6/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	60.0% 6/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Hernia pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Influenza like illness	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Localised oedema	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Malaise	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Mucosal inflammation	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Non-cardiac chest pain	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Oedema peripheral	22.0% 9/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	13.6% 6/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	24.0% 6/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Pain	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	25.0% 11/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Peripheral swelling	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Pyrexia	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.5% 9/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	54.5% 6/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	60.0% 6/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.0% 9/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 5/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Temperature intolerance	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Hepatic pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Immune system disorders Drug hypersensitivity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Immune system disorders Hypersensitivity	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Candida infection	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Conjunctivitis	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Cytomegalovirus infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Influenza	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Nasopharyngitis	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Pneumonia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Rash pustular	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Respiratory tract infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Rhinitis	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Sepsis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Sinusitis	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Skin infection	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Upper respiratory tract infection	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Urinary tract infection	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Contusion	12.2% 5/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Infusion related reaction	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Limb injury	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Activated partial thromboplastin time prolonged	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Alanine aminotransferase increased	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	45.5% 5/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 5/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Amylase increased	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Aspartate aminotransferase increased	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	54.5% 6/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	24.0% 6/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood alkaline phosphatase increased	12.2% 5/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood bilirubin increased	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood creatinine increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood thyroid stimulating hormone decreased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood thyroid stimulating hormone increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Cortisol increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Hepatic enzyme increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations International normalised ratio increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Lipase increased	19.5% 8/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 8/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Lymphocyte count decreased	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Norovirus test positive	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Platelet count decreased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Transaminases increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Weight decreased	19.5% 8/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Weight increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Decreased appetite	24.4% 10/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	34.1% 15/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	45.5% 5/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Dehydration	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyperglycaemia	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypokalaemia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypomagnesaemia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyponatraemia	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	66.7% 4/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypophosphataemia	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Malnutrition	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Arthralgia	19.5% 8/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	29.5% 13/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 5/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Back pain	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 8/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Flank pain	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Muscular weakness	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	13.6% 6/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Myalgia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	15.9% 7/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Neck pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Pain in extremity	17.1% 7/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Cerebrovascular accident	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Disturbance in attention	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dizziness	12.2% 5/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 8/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dysaesthesia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dysarthria	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Dysgeusia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Headache	24.4% 10/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.5% 9/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.0% 9/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 5/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Hemiparesis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Lethargy	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Neuropathy peripheral	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	6.8% 3/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Paraesthesia	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Presyncope	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Restless legs syndrome	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Seizure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Anxiety	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Confusional state	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Depression	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Insomnia	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Sleep disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Chromaturia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Dysuria	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Pollakiuria	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Reproductive system and breast disorders Nipple pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Reproductive system and breast disorders Spermatic cord haemorrhage	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Cough	24.4% 10/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	29.5% 13/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	36.4% 4/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	15.9% 7/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 3/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	50.0% 3/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 5/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Dry skin	17.1% 7/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 4/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Hyperhidrosis	7.3% 3/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Livedo reticularis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Pruritus	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	27.3% 12/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	72.7% 8/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	33.3% 2/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	32.0% 8/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	60.0% 6/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash	26.8% 11/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	25.0% 11/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	45.5% 5/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	24.0% 6/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	30.0% 3/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	12.2% 5/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	11.4% 5/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	40.0% 4/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.0% 4/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash papular	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Rash pruritic	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	12.0% 3/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Scab	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	20.0% 2/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Vitiligo	9.8% 4/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	13.6% 6/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	18.2% 2/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Embolism	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Flushing	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Hypertension	14.6% 6/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Hypotension	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	8.0% 2/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Lymphoedema	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Atrioventricular block second degree	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Cardiac disorders Cardiac failure congestive	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Ear and labyrinth disorders Cerumen impaction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Eye pruritus	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Eye swelling	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Iridocyclitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Lacrimation increased	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Ocular hyperaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Abdominal tenderness	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Ascites	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Autoimmune colitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Chronic gastritis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Faecaloma	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Gastrointestinal disorders Gastrooesophageal reflux disease	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Decreased activity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Feeling cold	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Feeling of body temperature change	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Gait disturbance	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Inflammation	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Physical deconditioning	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Bile duct obstruction	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Hepatobiliary disorders Cholelithiasis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Fungal skin infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Hordeolum	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Infected skin ulcer	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Oral herpes	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Pyuria	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Staphylococcal infection	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Bone fissure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Blood urea increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Investigations Heart rate increased	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Fluid retention	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Metabolism and nutrition disorders Hypophagia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour embolism	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Amnesia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Aphasia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Encephalopathy	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Fine motor delay	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Hypersomnia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Hypoaesthesia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Mental impairment	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Muscle spasticity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Neurotoxicity	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Somnolence	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Spinal cord compression	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Syncope	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Tremor	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Depressed mood	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Disorientation	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Hallucination	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Irritability	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Haematuria	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Nocturia	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Polyuria	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Urinary hesitation	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Renal and urinary disorders Urinary incontinence	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Reproductive system and breast disorders Genital rash	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Reproductive system and breast disorders Scrotal swelling	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Dysphonia	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.5% 2/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	16.7% 1/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	10.0% 1/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Erythema	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Night sweats	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Hot flush	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	9.1% 1/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Eye disorders Conjunctival oedema	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
General disorders Axillary pain	2.4% 1/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Infections and infestations Herpes zoster	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Injury, poisoning and procedural complications Fall	4.9% 2/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	2.3% 1/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Nervous system disorders Balance disorder	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	4.0% 1/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Psychiatric disorders Mental status changes	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Skin and subcutaneous tissue disorders Facial wasting	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).
Vascular disorders Orthostatic hypotension	0.00% 0/41 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/44 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/6 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/25 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/11 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	0.00% 0/10 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).	100.0% 1/1 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 73 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 73 months).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

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Email: [email protected]

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