Trial Outcomes & Findings for A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma (NCT NCT03606174)

Last Updated: 2023-08-24

Results Overview

ORR was defined as the number of participants documented to have a confirmed investigator-assessed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

260 participants

Primary outcome timeframe

Up to approximately 3 years

Results posted on

2023-08-24

Participant Flow

260 participants were enrolled into this study at investigative sites in the United States.

Screening tests and procedures were performed within the 28 days preceding administration of the first dose.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 3 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Dose Level 1 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Overall Study STARTED	49	23	18	9	53	27	56	9	8	4	4
Overall Study Started Cohort 9 Lead-in Dose-escalation Part	0	0	0	0	0	0	0	0	8	4	4
Overall Study Started Cohort 9 Dose-expansion Part	0	0	0	0	0	0	0	0	0	0	0
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	49	23	18	9	53	27	56	9	8	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 3 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Dose Level 1 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Overall Study Death	37	15	15	7	35	12	35	8	5	3	0
Overall Study Lost to Follow-up	0	0	0	0	1	1	0	0	0	0	0
Overall Study Withdrawal by Subject	6	0	0	1	2	1	4	0	0	0	1
Overall Study Study Terminated by Sponsor	5	7	3	0	11	6	12	1	3	1	2
Overall Study Miscellaneous	1	1	0	1	4	7	5	0	0	0	1

Baseline Characteristics

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Dose Level 1 n=8 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 2 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Total n=260 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 9.63 • n=5 Participants	72.3 years STANDARD_DEVIATION 7.94 • n=7 Participants	67.6 years STANDARD_DEVIATION 12.89 • n=5 Participants	75.1 years STANDARD_DEVIATION 7.62 • n=4 Participants	65.2 years STANDARD_DEVIATION 8.34 • n=21 Participants	70.0 years STANDARD_DEVIATION 8.23 • n=10 Participants	67.1 years STANDARD_DEVIATION 9.07 • n=115 Participants	78.0 years STANDARD_DEVIATION 7.02 • n=6 Participants	65.1 years STANDARD_DEVIATION 6.40 • n=6 Participants	69.0 years STANDARD_DEVIATION 8.00 • n=64 Participants	75.8 years STANDARD_DEVIATION 9.54 • n=17 Participants	68.3 years STANDARD_DEVIATION 9.39 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	17 Participants n=115 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	8 Participants n=4 Participants	43 Participants n=21 Participants	17 Participants n=10 Participants	39 Participants n=115 Participants	5 Participants n=6 Participants	8 Participants n=6 Participants	3 Participants n=64 Participants	3 Participants n=17 Participants	190 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	7 Participants n=4 Participants	52 Participants n=21 Participants	27 Participants n=10 Participants	53 Participants n=115 Participants	8 Participants n=6 Participants	8 Participants n=6 Participants	4 Participants n=64 Participants	4 Participants n=17 Participants	248 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	2 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	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	1 Participants n=17 Participants	10 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	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	14 Participants n=21 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	9 Participants n=4 Participants	46 Participants n=21 Participants	26 Participants n=10 Participants	48 Participants n=115 Participants	8 Participants n=6 Participants	8 Participants n=6 Participants	2 Participants n=64 Participants	3 Participants n=17 Participants	232 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	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Objective Response Rate (ORR)	4 Participants	0 Participants	17 Participants	6 Participants	5 Participants	9 Participants	3 Participants	0 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Day 1 up to approximately 3 years

Population: Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin).

An AE was defined as any reaction, side effect or other undesirable medical event that occurred during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Any clinically significant changes from baseline in laboratory results were recorded as AEs.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=8 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Number of Participants Who Experienced an Adverse Event (AE)	18 Participants	9 Participants	53 Participants	49 Participants	23 Participants	27 Participants	56 Participants	9 Participants	8 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 3 years

Population: Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin).

An SAE was defined as any event that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/permanent damage (substantial disruption of the ability to conduct normal life functions), a congenital anomaly/birth defect, or may have jeopardized the participant and may have required medical or surgical intervention to prevent intensive treatment in an emergency room or at home (e.g. for allergic bronchospasm, blood dyscrasias or convulsions) that do not result in inpatient hospitalization, development of drug dependency or drug abuse.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=8 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Number of Participants Who Experienced a Serious Adverse Event (SAE)	10 Participants	4 Participants	26 Participants	35 Participants	15 Participants	14 Participants	23 Participants	3 Participants	5 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 up to approximately 3 years

Population: Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin).

A treatment-related adverse event was defined as an adverse event determined to have a possible causal relationship to the study treatment(s) by the investigator. An adverse event was defined as any reaction, side effect or other undesirable medical event that occurred during participation in a clinical trial. Any clinically significant changes from baseline in laboratory results were recorded as adverse events.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=8 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Number of Participants Who Experienced a Treatment-related Adverse Event Sitravatinib Related	18 Participants	8 Participants	51 Participants	43 Participants	23 Participants	26 Participants	52 Participants	9 Participants	8 Participants	4 Participants	3 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event Nivolumab Related	15 Participants	7 Participants	41 Participants	41 Participants	23 Participants	24 Participants	35 Participants	4 Participants	NA Participants As pre-specified, participants did not receive nivolumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive nivolumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive nivolumab treatment in this Cohort.
Number of Participants Who Experienced a Treatment-related Adverse Event Pembrolizumab Related	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	NA Participants As pre-specified, participants did not receive pembrolizumab treatment in this Cohort.	6 Participants	3 Participants	3 Participants
Number of Participants Who Experienced a Treatment-related Adverse Event Enfortumab Vedotin Related	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	NA Participants As pre-specified, participants did not receive enfortumab vedotin treatment in this Cohort.	7 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: Measured in the Clinical Activity Evaluable Population-confirmed Response Subset, which included participants who achieved an objective response, received ≥1 dose of study treatment drug, had an evaluable baseline tumor assessment and ≥1 post-baseline tumor assessment. One participant in Cohort 6 who experienced a response wasn't included in DOR analysis because they didn't receive ≥1 dose of study treatment, have an evaluable baseline tumor assessment or ≥1 post-baseline tumor assessment.

DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) per RECIST V1.1, or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels.

Outcome measures

Outcome measures
Measure	Cohort 3 n=4 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=17 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=6 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=5 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=8 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=3 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=4 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Duration of Response (DOR)	11.762 months Interval 7.392 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	—	7.326 months Interval 5.52 to 12.977	5.585 months Interval 3.844 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	9.478 months Interval 5.782 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	16.361 months Interval 5.552 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	7.425 months Interval 5.552 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	—	11.8 months Interval 4.7 to Upper confidence intervals could not be calculated due to the low number of participants with a response.	—	—

SECONDARY outcome

Timeframe: Up to approximately 3 years

Clinical Benefit Rate (CBR) was defined as the number of participants documented to have a confirmed CR, PR, or stable disease (SD), per RECIST V1.1, documented during at least 1 on-study assessment. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. SD was defined as target lesions increasing by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Clinical Benefit Rate (CBR)	12 Participants	7 Participants	35 Participants	32 Participants	19 Participants	17 Participants	33 Participants	6 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 3 years

PFS was defined as the time from date of first study treatment to first PD per RECIST V1.1, or death due to any cause in the absence of documented PD.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Progression-Free Survival (PFS)	3.910 months Interval 1.873 to 9.133	3.515 months Interval 1.971 to Upper confidence intervals could not be calculated due to the low number of participants with a documented PD or death.	3.943 months Interval 3.45 to 5.651	3.877 months Interval 2.497 to 5.487	7.786 months Interval 3.943 to 14.62	5.421 months Interval 3.22 to 18.168	3.680 months Interval 2.234 to 5.52	3.713 months Interval 1.84 to Upper confidence intervals could not be calculated due to the low number of participants with a documented PD or death.	4.0 months Interval 2.04 to 6.51	—	—

SECONDARY outcome

Timeframe: 1 year

Survival was defined as the time from date of first study treatment to death due to any cause. Kaplan-Meier (product limit) estimates of the percentage of participants who died at 1-year was calculated to estimate the 1-year survival rate, defined as the percentage of participants alive at 1 year. Confidence Intervals were calculated based on Greenwood's formula. Participants who discontinued prior to 1-year were censored on the last date that they were known to be alive. For participants with no follow-up after first dose of study drug, survival rate was censored at the date of first dose (Day 1).

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
1-Year Survival Rate	55.6 percentage of participants Interval 30.5 to 74.8	44.4 percentage of participants Interval 13.6 to 71.9	53.9 percentage of participants Interval 39.5 to 66.3	42.5 percentage of participants Interval 27.9 to 56.4	56.5 percentage of participants Interval 34.3 to 73.8	57.1 percentage of participants Interval 36.0 to 73.6	32.6 percentage of participants Interval 19.5 to 46.3	16.7 percentage of participants Interval 1.1 to 49.3	41.5 percentage of participants Interval 15.4 to 66.1	—	—

SECONDARY outcome

Timeframe: Up to approximately 3 years

OS was defined as the time from date of first study treatment to death due to any cause.

Outcome measures

Outcome measures
Measure	Cohort 3 n=18 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Overall Survival (OS)	12.945 months Interval 5.618 to 22.439	5.092 months Interval 1.971 to 24.279	13.405 months Interval 5.782 to 21.29	8.049 months Interval 4.632 to 15.967	15.639 months Interval 7.655 to Data could not be calculated as too few participants experienced an event.	NA months Interval 5.947 to Data could not be calculated as too few participants experienced an event.	8.969 months Interval 7.359 to 10.809	7.556 months Interval 2.825 to 9.922	10.8 months Interval 2.69 to Data could not be calculated as too few participants experienced an event.	—	—

SECONDARY outcome

Timeframe: Cycle(C)1 Day(D)1 pre-dose, 30min, 2,4,6,7,8,24hr post-dose, C1D15 pre-dose, 30min,2,4,6,7,8,24hr post-dose, C2D1 pre-dose,7hr post-dose, C2D8,C3D1,C3D8,C5D1,C6D8 pre-dose (28 day cycles Cohorts 1-8, 21 day cycles Cohort 9)

Population: Measured in the Pharmacokinetic (PK) Evaluable Population, which included all participants who received treatment with sitravatinib and had available data at each timepoint. Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare PK endpoints across Cohort 9 dose levels.

Blood draws for analysis of blood plasma concentrations of sitravatinib were collected following electrocardiograms and assessment of vital signs. Concentration data below the limit of quantification were set to 0.

Outcome measures

Outcome measures
Measure	Cohort 3 n=17 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=49 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 Participants Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 n=16 Participants Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 4 Hours Post-Dose	31.21 ng/mL Geometric Coefficient of Variation 80.61	18.33 ng/mL Geometric Coefficient of Variation 158.02	23.72 ng/mL Geometric Coefficient of Variation 104.51	16.55 ng/mL Geometric Coefficient of Variation 168.43	21.46 ng/mL Geometric Coefficient of Variation 122.57	—	35.20 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 6 Hours Post-Dose	11.70 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	—	15.50 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	23.16 ng/mL Geometric Coefficient of Variation 69.50	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 7 Hours Post-Dose	20.08 ng/mL Geometric Coefficient of Variation 167.73	15.36 ng/mL Geometric Coefficient of Variation 108.29	23.13 ng/mL Geometric Coefficient of Variation 167.10	27.40 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	22.90 ng/mL Geometric Coefficient of Variation 121.87	23.13 ng/mL Geometric Coefficient of Variation 126.44	37.99 ng/mL Geometric Coefficient of Variation 50.79	31.21 ng/mL Geometric Coefficient of Variation 39.99	10.56 ng/mL Geometric Coefficient of Variation 41.43	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 8 Hours Post-Dose	12.10 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	—	23.00 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	26.08 ng/mL Geometric Coefficient of Variation 72.20	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 24 Hours Post-Dose	—	—	26.30 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	24.82 ng/mL Geometric Coefficient of Variation 71.41	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 Pre-Dose	42.03 ng/mL Geometric Coefficient of Variation 232.08	55.22 ng/mL Geometric Coefficient of Variation 34.39	50.58 ng/mL Geometric Coefficient of Variation 51.48	66.00 ng/mL Geometric Coefficient of Variation 52.30	50.21 ng/mL Geometric Coefficient of Variation 92.49	70.11 ng/mL Geometric Coefficient of Variation 67.12	49.94 ng/mL Geometric Coefficient of Variation 60.28	47.01 ng/mL Geometric Coefficient of Variation 39.78	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 30 Min Post-Dose	—	—	75.00 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	54.47 ng/mL Geometric Coefficient of Variation 77.06	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 2 Hours Post-Dose	—	—	67.80 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	62.50 ng/mL Geometric Coefficient of Variation 44.94	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 4 Hours Post-Dose	52.36 ng/mL Geometric Coefficient of Variation 111.45	95.35 ng/mL Geometric Coefficient of Variation 3.65	68.67 ng/mL Geometric Coefficient of Variation 52.79	70.90 ng/mL Geometric Coefficient of Variation 49.99	68.77 ng/mL Geometric Coefficient of Variation 23.87	45.27 ng/mL Geometric Coefficient of Variation 21.03	50.71 ng/mL Geometric Coefficient of Variation 33.36	55.30 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 6 Hours Post-Dose	—	—	82.90 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	67.45 ng/mL Geometric Coefficient of Variation 55.03	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 7 Hours Post-Dose	81.09 ng/mL Geometric Coefficient of Variation 85.63	62.78 ng/mL Geometric Coefficient of Variation 22.36	75.08 ng/mL Geometric Coefficient of Variation 45.43	—	89.19 ng/mL Geometric Coefficient of Variation 10.73	104.61 ng/mL Geometric Coefficient of Variation 26.97	76.70 ng/mL Geometric Coefficient of Variation 51.05	86.04 ng/mL Geometric Coefficient of Variation 2.22	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 8 Hours Post-Dose	—	—	95.20 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	72.12 ng/mL Geometric Coefficient of Variation 58.96	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 15 24 Hours Post-Dose	—	—	85.20 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	59.88 ng/mL Geometric Coefficient of Variation 52.20	—	—	—	—	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 2 Day 1 Pre-Dose	27.15 ng/mL Geometric Coefficient of Variation 459.38	48.24 ng/mL Geometric Coefficient of Variation 19.63	39.39 ng/mL Geometric Coefficient of Variation 101.75	28.06 ng/mL Geometric Coefficient of Variation 184.46	36.81 ng/mL Geometric Coefficient of Variation 107.98	32.81 ng/mL Geometric Coefficient of Variation 156.63	32.38 ng/mL Geometric Coefficient of Variation 155.83	46.89 ng/mL Geometric Coefficient of Variation 30.61	8.15 ng/mL Geometric Coefficient of Variation 274.13	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 2 Day 1 7 Hours Post-Dose	—	—	—	—	—	—	—	—	26.28 ng/mL Geometric Coefficient of Variation 68.42	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 2 Day 8 Pre-Dose	—	—	—	—	—	—	—	—	12.43 ng/mL Geometric Coefficient of Variation 476.36	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 3 Day 1 Pre-Dose	32.32 ng/mL Geometric Coefficient of Variation 56.61	56.40 ng/mL Geometric Coefficient of Variation 45.32	39.28 ng/mL Geometric Coefficient of Variation 48.02	29.10 ng/mL Geometric Coefficient of Variation 190.09	37.99 ng/mL Geometric Coefficient of Variation 126.82	20.02 ng/mL Geometric Coefficient of Variation 422.49	29.21 ng/mL Geometric Coefficient of Variation 140.39	19.39 ng/mL Geometric Coefficient of Variation 259.86	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 3 Day 8 Pre-Dose	—	—	—	—	—	—	—	—	7.53 ng/mL Geometric Coefficient of Variation 823.64	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 5 Day 1 Pre-Dose	44.45 ng/mL Geometric Coefficient of Variation 42.23	28.04 ng/mL Geometric Coefficient of Variation 81.00	26.48 ng/mL Geometric Coefficient of Variation 121.54	33.41 ng/mL Geometric Coefficient of Variation 41.39	40.39 ng/mL Geometric Coefficient of Variation 20.19	42.98 ng/mL Geometric Coefficient of Variation 39.16	37.55 ng/mL Geometric Coefficient of Variation 47.23	38.47 ng/mL Geometric Coefficient of Variation 20.17	—	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 6 Day 8 Pre-Dose	—	—	—	—	—	—	—	—	17.87 ng/mL Geometric Coefficient of Variation 105.74	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 Pre-dose	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	0 ng/mL Geometric Coefficient of Variation 0	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 30 Min Post-Dose	1.56 ng/mL Geometric Coefficient of Variation 176.68	0.91 ng/mL Geometric Coefficient of Variation 499.94	1.25 ng/mL Geometric Coefficient of Variation 266.58	1.85 ng/mL Geometric Coefficient of Variation 300.88	0.82 ng/mL Geometric Coefficient of Variation 10.95	1.28 ng/mL Geometric Coefficient of Variation 231.33	1.40 ng/mL Geometric Coefficient of Variation 268.79	0.25 ng/mL Geometric Coefficient of Variation 248.74	0.40 ng/mL Geometric Coefficient of Variation 172.86	—	—
Geometric Mean Blood Plasma Concentration of Sitravatinib Cycle 1 Day 1 2 Hours Post-Dose	6.94 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	—	24.90 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable PK samples at this time point.	5.69 ng/mL Geometric Coefficient of Variation 117.10	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 through pre-dose Cycle 2 Day 1 (cycle for Cohort 9 was 21 days)

Population: Measured in the DLT evaluable population, which, as pre-specified in the statistical analysis plan, was defined as participants who enrolled in the lead-in dose escalation portion of Cohort 9, who experienced a DLT or who cleared the DLT period.

A DLT was defined as any of the following events considered to be causally related to treatment with sitravatinib in combination with pembrolizumab and enfortumab in the lead-in dose escalation part of Cohort 9 (as pre-specified): hematological DLTs (Grade 4 neutropenia, thrombocytopenia, anemia unexplained by underlying disease, ≥Grade 3 febrile neutropenia or neutropenia with significant clinical sequelae, or any requirement for a platelet transfusion), non-hematological DLTs (≥Grade 4 infusion related reaction, non-hematological toxicity, Grade 3 infusion related reaction that does not resolve within 24 hours, hypertension that cannot be controlled with medical therapy), other Grade 3 non-hematologic toxicity lasting for \>3 days, with exceptions, Grade 2 pneumonitis or colitis, ≥Grade 3 non-hematological laboratory abnormalities, alanine transaminase\>3 x upper limit of normal (ULN) with bilirubin\> 2xULN, and other related toxic effects may have been assessed as DLTs.

Outcome measures

Outcome measures
Measure	Cohort 3 n=4 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 1 n=8 Participants Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=4 Participants Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants were enrolled to 3 dose levels of sitravatinib in combination with pembrolizumab and enfortumab vedotin. Sitravatinib was received orally via capsules QD in 21-day cycles at doses 35 mg and 70 mg. Pembrolizumab was received as an IV infusion over approximately 30 minutes (± 5 minutes) at 200 mg every 3 weeks (Q3W), in accordance with the current pembrolizumab USPI. Enfortumab vedotin dosing was based on participant weight, starting at 1.25 mg/kg up to 125 mg/kg QD, with a dose de-escalation step to 1 mg/kg. Enfortumab vedotin was received as an IV infusion over approximately 30 minutes (± 5 minutes) on Days 1 and 8 of a 21-day cycle.	Cohort 9 Dose Level 2 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Cohort 9 Lead-in Dose Escalation Part Only: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)	2 Participants	—	—	2 Participants	0 Participants	—	—	—	—	—	—

Adverse Events

Cohort 1

Serious events: 35 serious events

Other events: 49 other events

Deaths: 37 deaths

Cohort 2

Serious events: 15 serious events

Other events: 23 other events

Deaths: 15 deaths

Cohort 3

Serious events: 10 serious events

Other events: 18 other events

Deaths: 15 deaths

Cohort 4

Serious events: 4 serious events

Other events: 9 other events

Deaths: 7 deaths

Cohort 5

Serious events: 26 serious events

Other events: 53 other events

Deaths: 35 deaths

Cohort 6

Serious events: 14 serious events

Other events: 27 other events

Deaths: 12 deaths

Cohort 7

Serious events: 23 serious events

Other events: 56 other events

Deaths: 36 deaths

Cohort 8

Serious events: 3 serious events

Other events: 9 other events

Deaths: 8 deaths

Cohort 9 Dose Level 1

Serious events: 5 serious events

Other events: 8 other events

Deaths: 5 deaths

Cohort 9 Dose Level 2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Cohort 9 Dose Level 3

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=49 participants at risk Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 3 n=18 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 participants at risk Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 participants at risk Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Dose Level 1 n=8 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 2 n=4 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Anaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Cardiac failure congestive	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Adrenal insufficiency	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Hyperthyroidism	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Hypothyroidism	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal distension	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Ascites	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Constipation	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Diarrhoea	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Dysphagia	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Nausea	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Pancreatitis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Vomiting	6.1% 3/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Asthenia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Chills	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Fatigue	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Influenza like illness	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Infusion site extravasation	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Non-cardiac chest pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Pyrexia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Cellulitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Corona virus infection	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Kidney infection	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Pneumonia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Sepsis	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Skin infection	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Urinary tract infection	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Fall	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Alanine aminotransferase increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Amylase increased	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Aspartate aminotransferase increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood bilirubin increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood creatinine increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Ejection fraction decreased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Lipase increased	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Dizziness	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Headache	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Syncope	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Acute kidney injury	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Haematuria	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urinary incontinence	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urinary retention	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Embolism	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Hypertension	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Orthostatic hypotension	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Atrial fibrillation	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.

Other adverse events

Other adverse events
Measure	Cohort 1 n=49 participants at risk Participants with locally advanced or metastatic urothelial carcinoma (UC) with documented disease progression on or after previous anti-programmed cell death (PD)-ligand(L)-1 as most recent treatment, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 1. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules once daily (QD) in 28-day cycles. Nivolumab was received via an intravenous (IV) infusion over approximately 30 minutes (± 5 minutes) at 240 mg once every 2 weeks (Q2W) or 480 mg once every 4 weeks (Q4W), at the discretion of the Investigator and in accordance with the current nivolumab US Prescribing Information (USPI).	Cohort 2 n=23 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after previous anti-PD-L-1 as most recent treatment, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 2. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 3 n=18 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 3. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 4 n=9 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti-PD-(L)1 as the most recent treatment, who previously received (in combination or separately) other selected immunotherapies, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 4. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 5 n=53 participants at risk Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 5. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 6 n=27 participants at risk Participants with locally advanced or metastatic UC who had not previously received an anti-PD-(L)1, and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 6. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 120 mg capsules QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 7 n=56 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and antibody-drug conjugate (ADC) (in combination or separately, and in any order), and who were previously treated with a platinum-based chemotherapy were enrolled into Cohort 7. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 8 n=9 participants at risk Participants with locally advanced or metastatic UC with documented disease progression on or after a previous anti PD-(L)1 and ADC (in combination or separately, and in any order), and who were considered ineligible for platinum-based chemotherapy were enrolled into Cohort 8. Participants received sitravatinib in combination with nivolumab. Sitravatinib was received orally via 100 mg malate capsules, or 120 mg free base capsule formulation QD in 28-day cycles. Nivolumab was received via an IV infusion over approximately 30 minutes (± 5 minutes) at 240 mg Q2W or 480 mg Q4W, at the discretion of the Investigator and in accordance with the current nivolumab USPI.	Cohort 9 Dose Level 1 n=8 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 1 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.25 mg/kg IV infusion on Days 1 and 8 every 3 weeks (Q3W), and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 2 n=4 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 2 were enrolled to receive sitravatinib 35 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.	Cohort 9 Dose Level 3 n=4 participants at risk Participants with locally advanced or metastatic UC who had previously received a PD-(L)1 checkpoint inhibitor (CPI) and a platinum-based chemotherapy were enrolled into Cohort 9, which included a lead-in dose-escalation part. A dose-expansion part was planned, but was not enrolled. During the lead-in dose-escalation part, participants in Cohort 9 Dose Level 3 were enrolled to receive sitravatinib 70 mg QD orally via capsules in 21-day cycles, enfortumab vedotin 1.0 mg/kg IV infusion on Days 1 and 8 Q3W, and pembrolizumab 200 mg Q3W as an IV infusion.
Cardiac disorders Tachycardia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Oedema peripheral	26.5% 13/49 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	14.8% 4/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Pyrexia	12.2% 6/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	14.3% 8/56 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Anaemia	26.5% 13/49 • Number of events 27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	43.5% 10/23 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.9% 10/53 • Number of events 21 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.0% 10/27 • Number of events 27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.9% 10/56 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Neutropenia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Thrombocytopenia	4.1% 2/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Bradycardia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Cardiac failure congestive	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Cardiomegaly	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Palpitations	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Pericardial effusion	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Sinus tachycardia	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Ear and labyrinth disorders Tinnitus	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Adrenal insufficiency	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Androgen deficiency	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Hyperthyroidism	8.2% 4/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Hypogonadism male	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Endocrine disorders Hypothyroidism	38.8% 19/49 • Number of events 20 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 8/18 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.4% 14/53 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	29.6% 8/27 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	23.2% 13/56 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Dry eye	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Eye disorder	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Eye pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Eyelid margin crusting	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Scleral discolouration	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Vision blurred	6.1% 3/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Eye disorders Vitreous floaters	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal distension	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal pain	16.3% 8/49 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 8/18 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.0% 9/53 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 12/27 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	10.7% 6/56 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal pain lower	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Abdominal pain upper	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Ascites	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Constipation	32.7% 16/49 • Number of events 20 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	27.8% 5/18 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	32.1% 17/53 • Number of events 26 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 12/27 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 17/56 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 4/8 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Diarrhoea	59.2% 29/49 • Number of events 66 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	87.0% 20/23 • Number of events 52 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	72.2% 13/18 • Number of events 24 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	64.2% 34/53 • Number of events 109 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	66.7% 18/27 • Number of events 33 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	55.4% 31/56 • Number of events 66 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 4/8 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Dry mouth	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 7/56 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Dyspepsia	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Dysphagia	8.2% 4/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Faeces discoloured	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Flatulence	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Gingival pain	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Haemorrhoids	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Nausea	40.8% 20/49 • Number of events 37 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	52.2% 12/23 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	38.9% 7/18 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	35.8% 19/53 • Number of events 26 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	48.1% 13/27 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 17/56 • Number of events 23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	55.6% 5/9 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Odynophagia	4.1% 2/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Oral dysaesthesia	12.2% 6/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Oral pain	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Pancreatitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Retching	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Stomatitis	22.4% 11/49 • Number of events 19 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	38.9% 7/18 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.9% 10/56 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Gastrointestinal disorders Vomiting	30.6% 15/49 • Number of events 23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 7/23 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.2% 16/53 • Number of events 22 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	19.6% 11/56 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Asthenia	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Axillary pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Chest discomfort	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Chills	10.2% 5/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Face oedema	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Fatigue	71.4% 35/49 • Number of events 67 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	82.6% 19/23 • Number of events 46 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	83.3% 15/18 • Number of events 28 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	60.4% 32/53 • Number of events 54 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	63.0% 17/27 • Number of events 27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	42.9% 24/56 • Number of events 33 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.5% 3/8 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Feeling cold	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Gait disturbance	2.0% 1/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Influenza like illness	2.0% 1/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Infusion site extravasation	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Localised oedema	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Malaise	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Mucosal inflammation	8.2% 4/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Non-cardiac chest pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.1% 4/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
General disorders Temperature intolerance	6.1% 3/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Bronchitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Candida infection	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Cellulitis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Conjunctivitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Corona virus infection	2.0% 1/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Cystitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Ear infection	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Fungal skin infection	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Kidney infection	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Onychomycosis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Oral candidiasis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Pneumonia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Rash pustular	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Sepsis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Sinusitis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Skin infection	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Tooth infection	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Infections and infestations Urinary tract infection	16.3% 8/49 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	34.8% 8/23 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 7/56 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Fall	12.2% 6/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Medication error	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Procedural pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Alanine aminotransferase increased	34.7% 17/49 • Number of events 22 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	34.8% 8/23 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	43.4% 23/53 • Number of events 40 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	51.9% 14/27 • Number of events 23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.8% 15/56 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Amylase increased	20.4% 10/49 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	21.7% 5/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 17 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.1% 4/56 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Aspartate aminotransferase increased	28.6% 14/49 • Number of events 19 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	27.8% 5/18 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	34.0% 18/53 • Number of events 26 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	51.9% 14/27 • Number of events 32 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 17/56 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.5% 3/8 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood albumin decreased	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood alkaline phosphatase increased	16.3% 8/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	21.7% 5/23 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	10.7% 6/56 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood bilirubin increased	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood creatinine increased	20.4% 10/49 • Number of events 21 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	32.1% 17/53 • Number of events 27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	29.6% 8/27 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	10.7% 6/56 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood glucose increased	6.1% 3/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood thyroid stimulating hormone increased	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood triglycerides increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Blood urea increased	4.1% 2/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Ejection fraction decreased	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Lipase increased	20.4% 10/49 • Number of events 22 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	27.8% 5/18 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 24 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.9% 10/56 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Lymphocyte count decreased	10.2% 5/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Neutrophil count decreased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Platelet count decreased	10.2% 5/49 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Troponin T increased	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations Weight decreased	30.6% 15/49 • Number of events 25 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	56.5% 13/23 • Number of events 20 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.4% 14/53 • Number of events 26 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	40.7% 11/27 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	21.4% 12/56 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Investigations White blood cell count decreased	4.1% 2/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Cachexia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Decreased appetite	46.9% 23/49 • Number of events 41 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	78.3% 18/23 • Number of events 26 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	66.7% 12/18 • Number of events 21 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	60.4% 32/53 • Number of events 51 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	51.9% 14/27 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 17/56 • Number of events 24 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Dehydration	10.2% 5/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypercalcaemia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyperglycaemia	12.2% 6/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyperkalaemia	6.1% 3/49 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyperuricaemia	8.2% 4/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypoalbuminaemia	18.4% 9/49 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 7/23 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	29.6% 8/27 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypocalcaemia	6.1% 3/49 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypokalaemia	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	14.8% 4/27 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.1% 4/56 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypomagnesaemia	12.2% 6/49 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	15.1% 8/53 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	10.7% 6/56 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hyponatraemia	12.2% 6/49 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	27.8% 5/18 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.2% 16/53 • Number of events 29 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	14.3% 8/56 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Arthralgia	22.4% 11/49 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.9% 10/53 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	19.6% 11/56 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	12.2% 6/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	20.8% 11/53 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	14.3% 8/56 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Coccydynia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Flank pain	8.2% 4/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Gouty arthritis	2.0% 1/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Muscle spasms	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Muscular weakness	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	30.4% 7/23 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Myalgia	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Musculoskeletal and connective tissue disorders Pain in extremity	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	10.2% 5/49 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Amnesia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Ataxia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Disturbance in attention	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Dizziness	16.3% 8/49 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.4% 14/53 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 12/27 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	19.6% 11/56 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.5% 3/8 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Dysarthria	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Dysgeusia	20.4% 10/49 • Number of events 18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	21.7% 5/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.1% 4/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Headache	16.3% 8/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.0% 9/53 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.1% 9/56 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Hyperreflexia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Lethargy	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Memory impairment	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Migraine	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Neuropathy peripheral	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Paraesthesia	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Peripheral sensory neuropathy	2.0% 1/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Seizure	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Nervous system disorders Syncope	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.5% 3/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Anxiety	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Confusional state	6.1% 3/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Delirium	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Depression	10.2% 5/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Insomnia	20.4% 10/49 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Irritability	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Psychiatric disorders Tangentiality	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Acute kidney injury	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Bladder spasm	8.2% 4/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Chromaturia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Chronic kidney disease	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Cystitis noninfective	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Dysuria	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Haematuria	24.5% 12/49 • Number of events 14 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	20.8% 11/53 • Number of events 19 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.9% 10/56 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	62.5% 5/8 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Micturition urgency	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Nephritis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Nocturia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Pollakiuria	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.3% 6/53 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Proteinuria	14.3% 7/49 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Renal pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urinary incontinence	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urinary retention	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urinary tract obstruction	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Renal and urinary disorders Urine flow decreased	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Pelvic pain	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Penile pain	4.1% 2/49 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Penile swelling	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Perineal pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Testicular pain	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 7/49 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.6% 12/53 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.9% 7/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 7/56 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	37.5% 3/8 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dysphonia	38.8% 19/49 • Number of events 23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	65.2% 15/23 • Number of events 19 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 9/18 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.6% 21/53 • Number of events 28 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 9/27 • Number of events 13 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	41.1% 23/56 • Number of events 23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	55.6% 5/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.3% 7/49 • Number of events 9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.1% 9/23 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 4/18 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	35.8% 19/53 • Number of events 30 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 7/56 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Hiccups	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.1% 3/49 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.2% 6/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.5% 4/53 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.7% 2/23 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Blister	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Dermatitis acneiform	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Dry skin	12.2% 6/49 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	20.4% 10/49 • Number of events 20 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	21.7% 5/23 • Number of events 11 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	38.9% 7/18 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 3/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	24.5% 13/53 • Number of events 17 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	18.5% 5/27 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 12 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 2/9 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Pruritus	8.2% 4/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	17.4% 4/23 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.2% 7/53 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	10.7% 6/56 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 2/8 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	50.0% 2/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rash	12.2% 6/49 • Number of events 10 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	13.0% 3/23 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.7% 3/53 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.7% 1/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.4% 3/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.2% 4/49 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	26.1% 6/23 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	16.7% 3/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	20.8% 11/53 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	22.2% 6/27 • Number of events 7 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	8.9% 5/56 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Rosacea	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Skin exfoliation	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Skin lesion	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 2/18 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.9% 1/53 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	12.5% 1/8 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Skin and subcutaneous tissue disorders Skin ulcer	4.1% 2/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	9.4% 5/53 • Number of events 6 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Embolism	6.1% 3/49 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	7.4% 2/27 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.6% 2/56 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Haematoma	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/23 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	5.6% 1/18 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Hypertension	28.6% 14/49 • Number of events 32 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	52.2% 12/23 • Number of events 19 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	33.3% 6/18 • Number of events 16 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 5 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	39.6% 21/53 • Number of events 29 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 12/27 • Number of events 15 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	48.2% 27/56 • Number of events 43 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	44.4% 4/9 • Number of events 4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	75.0% 3/4 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Hypotension	2.0% 1/49 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	3.8% 2/53 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 3/27 • Number of events 3 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	1.8% 1/56 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 2 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.
Vascular disorders Orthostatic hypotension	0.00% 0/49 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	4.3% 1/23 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/18 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	11.1% 1/9 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/53 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/27 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/56 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/9 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/8 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	0.00% 0/4 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.	25.0% 1/4 • Number of events 1 • Day 1 up to approximately 3 years All cause mortality, serious adverse events and other adverse events are reported for all enrolled participants.

Additional Information

Director, Clinical Operations

Mirati Therapeutics

Phone: 858-381-5289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place