Trial Outcomes & Findings for MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients (NCT NCT04212221)

Last Updated: 2024-07-23

Results Overview

DLT was defined as the adverse events (AEs) listed in the protocol occurring within 4 weeks (the first 2 cycles, 28 days) after the investigational drugs which were at least possibly related to the study drugs. AE severity was graded from 1 to 5 according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

89 participants

Primary outcome timeframe

The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study.

Results posted on

2024-07-23

Participant Flow

The study consists of two phases: Phase I dose escalation and Phase II dose expansion. A total of 89 participants were enrolled in the study across 16 centers in China, including 82 participants who received at least one dose of MGD013 and 7 participants who received at least one dose of MGD013 in combination with Brivanib alaninate.

Participant milestones

Participant milestones
Measure	Phase 1: MGD013 120mg Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Overall Study STARTED	1	3	3	6	3	4	33	36
Overall Study COMPLETED	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	3	3	6	3	4	33	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: MGD013 120mg Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Overall Study Remained on Treatment	0	0	0	1	0	0	3	9
Overall Study Adverse Event	0	0	0	0	0	0	2	3
Overall Study Death	0	0	0	0	0	0	0	2
Overall Study Disease progression according to irRECIST	1	2	3	3	2	2	21	17
Overall Study Global Deterioration of Health Status	0	0	0	0	0	0	0	2
Overall Study Investigator's Decision	0	0	0	1	0	0	3	0
Overall Study Participant refused to continue treatment	0	1	0	1	1	2	4	2
Overall Study Protocol Violation	0	0	0	0	0	0	0	1

Baseline Characteristics

MGD013 Monotherapy and Combination With Brivanib Dose Escalation and Expansion Study in Advanced Liver Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort n=33 Participants Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort n=36 Participants Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Total n=89 Participants Total of all reporting groups
Age, Customized Age Group · < 65 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	26 Participants n=115 Participants	26 Participants n=6 Participants	60 Participants n=6 Participants
Age, Customized Age Group · ≥ 65 Years	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=10 Participants	7 Participants n=115 Participants	10 Participants n=6 Participants	29 Participants n=6 Participants
Sex: Female, Male Female	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	1 Participants n=10 Participants	7 Participants n=115 Participants	2 Participants n=6 Participants	10 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	26 Participants n=115 Participants	34 Participants n=6 Participants	79 Participants n=6 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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	33 Participants n=115 Participants	36 Participants n=6 Participants	89 Participants n=6 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	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
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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: The first two cycles (Cycle 1 and Cycle 2) of the study treatment(s). A cycle lasted for two weeks (14 days) in the study.

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: AEs would be collected throughout the clinical trial, from the signing of the informed consent form (ICF) to the end of the trial (until 30 days after the last dose of investigational drugs). Up to approximately 24 months.

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

All adverse events (AEs) occurring on or after the first study treatment were listed and summarized. Treatment-Emergent Adverse Event (TEAE) was defined as an AE that had an onset date or a worsening in severity from baseline on or after the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment (any component of combination treatment whichever was last) discontinuation. All adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort n=33 Participants Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort n=36 Participants Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 1 and Phase 2: Safety Treatment-Related TEAEs	1 Participants	2 Participants	3 Participants	6 Participants	3 Participants	4 Participants	23 Participants	27 Participants
Phase 1 and Phase 2: Safety Patients with at Least One TEAE	1 Participants	3 Participants	3 Participants	6 Participants	3 Participants	4 Participants	31 Participants	34 Participants
Phase 1 and Phase 2: Safety TEAEs with Grade 3 or Higher	1 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	11 Participants	10 Participants
Phase 1 and Phase 2: Safety Serious TEAEs	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	10 Participants	8 Participants
Phase 1 and Phase 2: Safety TEAEs Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1 and Phase 2: Safety TEAEs Leading to Treatment Discontinuation of Any Treatment Component	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Phase 1 and Phase 2: Safety Treatment-Related TEAEs with Grade 3 or Higher	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	5 Participants	8 Participants
Phase 1 and Phase 2: Safety Treatment-Related Serious TEAEs	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants	6 Participants
Phase 1 and Phase 2: Safety Treatment-Related TEAEs Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Phase 1 and Phase 2: Safety Treatment-Related TEAEs Leading to Treatment Discontinuation of Any Treatment Component	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Phase 1 and Phase 2: Safety Treatment-Related TEAEs Leading to Dose Modification of Any Treatment Component	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	3 Participants	7 Participants	12 Participants
Phase 1 and Phase 2: Safety TEAEs Leading to Dose Modification of Any Treatment Component	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants	3 Participants	13 Participants	15 Participants

PRIMARY outcome

Timeframe: Radiologic examinations were conducted at baseline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first) in phase 2.

ORR was defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), before progression based on RECIST v1.1. Participants who had no measurable disease at baseline and/or no post-baseline tumor assessment due to any reason will be considered nonresponders. An estimate of ORR was calculated for each treatment arm, and its 95% CI was calculated using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=33 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=36 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) According to RECIST 1.1	3.0 percentage of participants Interval 0.08 to 15.76	8.3 percentage of participants Interval 1.75 to 22.47	—	—	—	—	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=33 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=36 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1	3.0 percentage of participants Interval 0.08 to 15.76	11.1 percentage of participants Interval 3.11 to 26.06	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Radiologic examinations were conducted at basline within 28 days prior to the start of study medication and every 8 weeks (±7 days) dated from the first day of the first cycle until disease progression. Up to approximately 24 months.

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

DCR was defined as the percentage of participants who attained a best overall response status of CR, PR, and SD. If best overall response is SD, the SD should be stable SD, that is the date of SD should be at least 6 weeks after first dose. DCR was analyzed using the same methodology as specified for ORR.

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=33 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=36 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Disease Control Rate (DCR) by BICR / Investigator Assessment According to RECIST 1.1 DCR by BICR Assessment	33.3 percentage of participants Interval 17.96 to 51.83	30.6 percentage of participants Interval 16.35 to 48.11	—	—	—	—	—	—
Phase 2: Disease Control Rate (DCR) by BICR / Investigator Assessment According to RECIST 1.1 DCR by Investigator Assessment	45.5 percentage of participants Interval 28.11 to 63.65	38.9 percentage of participants Interval 23.14 to 56.54	—	—	—	—	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

TTR was defined as the time from the first dose date to the date of the earliest confirmed response assessed using RECIST V1.1. Only responders were included in the analysis.

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=4 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Time to Response (TTR) by Investigator Assessment According to RECIST 1.1	1.70 months Interval 1.7 to 1.7	1.80 months Interval 1.7 to 3.5	—	—	—	—	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

DoR was defined for subjects with a confirmed objective response as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurred first. Participants who had no progression or death would be censored.

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=4 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Duration of Response (DoR) by Investigator Assessment According to RECIST 1.1	9.20 months Interval 9.2 to 9.2	5.80 months Interval 3.7 to 5.8	—	—	—	—	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

PFS was defined as the time from the date of first dose of study treatment (any component of combination treatment whichever is first) to the first documented disease progression as determined by the investigator or BICR with the use of RECIST v1.1, or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS for each treatment arm and to construct survival curves for each treatment arm. The Brookmeyer-Crowley methodology was used to construct the 95% CI for the median PFS for each treatment arm (Brookmeyer and Crowley 1982).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=33 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=36 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Progression-Free Survival (PFS) by Investigator Assessment According to RECIST 1.1	2.40 months Interval 1.9 to 4.1	3.05 months Interval 1.9 to 5.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first dose of study treatment to the date of death from any cause. Up to approximately 24 months.

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

OS was defined as the time from the date of the first dose of study treatment (any component of combination treatment whichever was first) to the date of death from any cause. Participants who were alive at the time of the analysis data cutoff would be censored at the last date they were known to be alive. Participants with no post-baseline information were censored at the date of the first dose of study treatment (any study treatment component for combo therapy).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=33 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=36 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 2: Overall Survival (OS)	NA months Interval 9.7 to The median and the upper bound of the confidence interval could not be estimated because of insufficient number of events.	NA months Interval 7.1 to The median and the upper bound of the confidence interval could not be estimated because of insufficient number of events.	—	—	—	—	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 1: Objective Response Rate (ORR) by Investigator Assessment According to RECIST 1.1	0 percentage of participants Interval 0.0 to 97.5	33.3 percentage of participants Interval 0.84 to 90.57	0 percentage of participants Interval 0.0 to 70.76	16.7 percentage of participants Interval 0.42 to 64.12	0 percentage of participants Interval 0.0 to 70.76	0 percentage of participants Interval 0.0 to 60.24	—	—

SECONDARY outcome

Population: All patients who received at least one dose of study treatment (any component of combination treatment whichever is first).

Outcome measures

Outcome measures
Measure	Phase 1: MGD013 120mg n=1 Participants Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 Participants Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 Participants Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 Participants Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Phase 1: Disease Control Rate (DCR) by Investigator Assessment According to RECIST 1.1	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 29.24 to 100.0	33.3 percentage of participants Interval 0.84 to 90.57	16.7 percentage of participants Interval 0.42 to 64.12	0 percentage of participants Interval 0.0 to 70.76	25.0 percentage of participants Interval 0.63 to 80.59	—	—

Adverse Events

Phase 1: MGD013 120mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 1: MGD013 240mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: MGD013 400mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: MGD013 600mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Phase 1: MGD013 400mg + Brivanib 400mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1: MGD013 600mg + Brivanib 400mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase 2: MGD013 600mg Post-CPI Cohort

Serious events: 10 serious events

Other events: 30 other events

Deaths: 10 deaths

Phase 2: MGD013 600mg CPI-naive Cohort

Serious events: 8 serious events

Other events: 34 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: MGD013 120mg n=1 participants at risk Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 participants at risk Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 participants at risk Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 participants at risk Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 participants at risk Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 participants at risk Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort n=33 participants at risk Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort n=36 participants at risk Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Investigations White blood cell count decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Endocrine disorders Adrenal insufficiency	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Pyrexia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Hepatobiliary disorders Liver injury	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Infections and infestations Biliary tract infection	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Platelet count decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Nervous system disorders Loss of consciousness	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Vascular disorders Hypotension	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.

Other adverse events

Other adverse events
Measure	Phase 1: MGD013 120mg n=1 participants at risk Participants received 120 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 240mg n=3 participants at risk Participants received 240 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg n=3 participants at risk Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 600mg n=6 participants at risk Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 1: MGD013 400mg + Brivanib 400mg n=3 participants at risk Participants received 400 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 1: MGD013 600mg + Brivanib 400mg n=4 participants at risk Participants received 600 mg MGD013 intravenously once every 2 weeks (Q2W), in combination with 400 mg Brivanib alaninate orally once daily (QD).	Phase 2: MGD013 600mg Post-CPI Cohort n=33 participants at risk Participants who had received at least one prior line of systemic therapy including prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).	Phase 2: MGD013 600mg CPI-naive Cohort n=36 participants at risk Participants who had received at least one prior line of systemic therapy without prior immune checkpoint inhibitor (CPI) treatment received 600 mg MGD013 intravenously once every 2 weeks (Q2W).
Nervous system disorders Headache	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Psychiatric disorders Insomnia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Renal and urinary disorders Haematuria	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Renal and urinary disorders Proteinuria	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	12.1% 4/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 6/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	21.2% 7/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	24.2% 8/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Social circumstances Inadequate diet	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Vascular disorders Hypertension	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	19.4% 7/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Cardiac disorders Cardiac failure	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Cardiac disorders Sinus bradycardia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Endocrine disorders Hyperthyroidism	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Endocrine disorders Hypothyroidism	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Alanine aminotransferase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	12.1% 4/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	30.6% 11/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	11.1% 4/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Ascites	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Constipation	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Dry mouth	100.0% 1/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations C-reactive protein increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Nausea	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Gastrointestinal disorders Vomiting	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	11.1% 4/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Asthenia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 3/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Fatigue	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Influenza like illness	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Malaise	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Oedema peripheral	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Pain	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
General disorders Pyrexia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	18.2% 6/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Infections and infestations Pneumonia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Infections and infestations Upper respiratory tract infection	100.0% 1/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Infections and infestations Urinary tract infection	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Tongue injury	100.0% 1/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Alpha hydroxybutyrate dehydrogenase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Amylase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	11.1% 4/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 4/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	21.2% 7/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 9/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Bilirubin conjugated increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 4/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood bilirubin increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 3/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	12.1% 4/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	27.8% 10/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood bilirubin unconjugated increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood creatinine increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Blood urea increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Free fatty acids increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Gamma-glutamyltransferase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Hepatitis B DNA increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations International normalised ratio increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Lipase increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Neutrophil count decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	11.1% 4/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Platelet count decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	21.2% 7/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	22.2% 8/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Protein urine present	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Prothrombin level decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Prothrombin time prolonged	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Total bile acids increased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Tri-iodothyronine decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Tri-iodothyronine free decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations Urine ketone body present	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Investigations White blood cell count decreased	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 2/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	11.1% 4/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hyperglycaemia	100.0% 1/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	12.1% 4/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	13.9% 5/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	9.1% 3/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 4/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	66.7% 2/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	50.0% 2/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	15.2% 5/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	8.3% 3/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	12.1% 4/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	33.3% 1/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	15.2% 5/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Musculoskeletal and connective tissue disorders Myalgia	100.0% 1/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	2.8% 1/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	16.7% 1/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	3.0% 1/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.
Nervous system disorders Dizziness	0.00% 0/1 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/6 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	0.00% 0/3 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	25.0% 1/4 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	6.1% 2/33 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.	5.6% 2/36 • From the date of administration of the first dose of study treatment (any component of combination treatment whichever is first) up to 30 days following study treatment discontinuation (any component of combination treatment whichever is last). Adverse event reporting for all-cause mortality considers all deaths that occurred during the study. Up to approximately 24 months.

Additional Information

Medical Director

Zai Lab (Shanghai) Co.,Ltd.

Phone: +86 4008201022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place