Trial Outcomes & Findings for Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC (NCT NCT04524689)

Last Updated: 2025-10-29

Results Overview

DLTs were defined as: a) Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever (temperature ≥38.5 degree Celsius on more than 1 occasion) or microbiologically or radiographically documented infection, grade ≥3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention; b) Non-hematological abnormalities: grade 4 non-hematologic adverse event (AE), except AE symptoms related to the underlying disease as per the Investigator's judgment, grade ≥3 keratopathy. In addition, any other AE that the recruiting Investigators and sponsor deemed to be dose-limiting, regardless of its grade, was also considered as DLT.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

57 participants

Primary outcome timeframe

Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)

Results posted on

2025-10-29

Participant Flow

The study was conducted at 22 centers in 8 countries. A total of 68 participants were screened from 26 October 2020 to 19 December 2023, of which 11 were screen failures. Screen failures were mainly due to not meeting the eligibility criteria. The study was terminated due to the discontinuation of the overall development of tusamitamab ravtansine by the Sponsor.

A total of 57 participants were enrolled in either Part A \[doublet cohort (tusamitamab ravtansine + pembrolizumab)\], Part B \[triplet cohort (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy i.e., cisplatin or carboplatin)\] or Part C \[quadruplet cohort (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)\] of the study per Investigator's choice.

Participant milestones

Participant milestones
Measure	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 150 milligram per square meter (mg/m\^2) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion on Day 1 and then every 3 weeks (Q3W) until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin area under the curve (AUC) 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Overall Study STARTED	23	2	6	1	22	3
Overall Study COMPLETED	7	1	4	1	16	2
Overall Study NOT COMPLETED	16	1	2	0	6	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 150 milligram per square meter (mg/m\^2) along with pembrolizumab 200 milligram (mg) via intravenous (IV) infusion on Day 1 and then every 3 weeks (Q3W) until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin area under the curve (AUC) 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Overall Study Withdrawal by Subject	1	1	0	2	0
Overall Study Study terminated by Sponsor	6	0	1	4	0
Overall Study Not related to Coronavirus disease 2019	9	0	1	0	1

Baseline Characteristics

Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=22 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Total n=57 Participants Total of all reporting groups	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Age, Customized < 65 years	3 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	2 Participants n=8 Participants	24 Participants n=8 Participants	10 Participants n=5 Participants	0 Participants n=7 Participants
Age, Customized 65 to 74 years	1 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants	1 Participants n=8 Participants	26 Participants n=8 Participants	9 Participants n=5 Participants	2 Participants n=7 Participants
Age, Customized ≥ 75 years	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=5 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	1 Participants n=8 Participants	25 Participants n=8 Participants	11 Participants n=5 Participants	1 Participants n=7 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants	2 Participants n=8 Participants	32 Participants n=8 Participants	12 Participants n=5 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=8 Participants	43 Participants n=8 Participants	20 Participants n=5 Participants	2 Participants n=7 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized Not reported	1 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=5 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 up to Cycle 1 Day 21 (cycle duration=3 weeks)

Population: DLT-evaluable population included participants who received 1 cycle with at least 80% of the intended dose for each study treatment of the combination during the safety run-in at both doses of tusamitamab ravtansine in Part A (doublet cohort), Part B (triplet cohort) or Part C (quadruplet cohort).

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=21 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=5 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=21 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Number of Participants With Study Drug-Related Dose-Limiting Toxicities (DLTs)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks

Population: All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part A (doublet cohort) at both tusamitamab ravtansine doses.

ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Doublet Cohort: Objective Response Rate (ORR)	—	47.8 percentage of participants Interval 26.82 to 69.41	0 percentage of participants Interval 0.0 to 84.19	—	—	—

PRIMARY outcome

Timeframe: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 139.9 weeks

Population: All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

ORR was defined as the percentage of participants with a confirmed CR or PR as per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=22 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=3 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Quadruplet Cohort: Objective Response Rate	—	59.1 percentage of participants Interval 36.35 to 79.29	66.7 percentage of participants Interval 9.43 to 99.16	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE was defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity or was a congenital anomaly/birth defect. A TEAE was defined as an AE that developed, worsened or became serious during the treatment-emergent period.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=22 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE	3 Participants	23 Participants	2 Participants	6 Participants	1 Participants	22 Participants
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TESAE	2 Participants	9 Participants	0 Participants	1 Participants	1 Participants	11 Participants

SECONDARY outcome

Timeframe: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet) and 139.9 weeks (quadruplet)

PFS was defined as the time from the first study treatment administration to the date of the first documented progressive disease (PD) or death due to any cause, whichever came first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=22 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=3 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Doublet and Quadruplet Cohorts: Progression-free Survival (PFS)	—	28.45 months Interval 4.107 to NA indicates that the upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.	NA months Interval 2.891 to NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.	11.56 months Interval 5.52 to 15.869	NA months Interval 5.388 to NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 158.4 weeks (doublet), 113 weeks (triplet), and 139.9 weeks (quadruplet)

DCR was defined as percentage of participants with a confirmed CR, confirmed PR or stable disease (SD) as BOR per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=22 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Disease Control Rate (DCR)	100 percentage of participants Interval 29.24 to 100.0	82.6 percentage of participants Interval 61.22 to 95.05	100 percentage of participants Interval 15.81 to 100.0	100 percentage of participants Interval 54.07 to 100.0	100 percentage of participants Interval 2.5 to 100.0	81.8 percentage of participants Interval 59.72 to 94.81

SECONDARY outcome

Population: All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Only participants with confirmed CR or PR as BOR were included in the analysis. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

DOR was defined as the time from first documented evidence of CR or PR until PD determined per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered progression.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=2 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=11 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=4 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=13 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Duration of Response (DOR)	NA months Interval 4.074 to NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.	NA months Interval 7.688 to NA indicates that the median and upper limit of 95% CI were not estimable due to insufficient number of participants with events.	—	10.45 months Interval 7.589 to NA indicates that the upper limit of 95% CI was not estimable due to insufficient number of participants with events.	—	12.02 months Interval 8.345 to 19.22

SECONDARY outcome

Timeframe: Tumor assessments performed at baseline, then every 6 weeks for first 24 weeks, and every 9 weeks thereafter, approximately 113 weeks

Population: All-treated population included all participants assigned to study treatment and who actually received at least 1 dose of study treatment. Data is reported for Part B (triplet cohort) at both tusamitamab ravtansine doses.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=6 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=1 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Triplet Cohort: Objective Response Rate	—	66.7 percentage of participants Interval 22.28 to 95.67	0 percentage of participants Interval 0.0 to 97.5	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)

Population: PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

Blood samples were collected for the measurement of tusamitamab ravtansine concentrations.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=2 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=16 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=4 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=17 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Trough Concentration (Ctrough) of Tusamitamab Ravtansine	7.6 microgram per milliliter (mcg/mL) Standard Deviation 0.9	8.0 microgram per milliliter (mcg/mL) Standard Deviation 3.5	11.7 microgram per milliliter (mcg/mL) Standard Deviation 1.5	7.6 microgram per milliliter (mcg/mL) Standard Deviation 8.0	0.0 microgram per milliliter (mcg/mL) Standard Deviation NA NA indicates that the standard deviation was not estimable for only 1 participant.	4.8 microgram per milliliter (mcg/mL) Standard Deviation 2.7

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycle 2 (cycle duration=3 weeks)

Blood samples were collected for the measurement of pembrolizumab concentrations.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=2 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=3 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=4 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=17 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Ctrough of Pembrolizumab	10.3 mcg/mL Standard Deviation 1.3	14.0 mcg/mL Standard Deviation 2.2	16.9 mcg/mL Standard Deviation 4.8	13.4 mcg/mL Standard Deviation 5.7	14.1 mcg/mL Standard Deviation NA NA indicates that the standard deviation was not estimable for only 1 participant.	13.2 mcg/mL Standard Deviation 4.2

SECONDARY outcome

Timeframe: 30 minutes post-dose on Day 1 of Cycle 1 (cycle duration=3 weeks)

Population: PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

Blood samples were collected for the measurement of pemetrexed concentrations.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=19 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=3 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Quadruplet Cohort: Plasma Concentration of Pemetrexed	—	68.5 mcg/mL Standard Deviation 80.8	53.6 mcg/mL Standard Deviation 48.3	—	—	—

SECONDARY outcome

Timeframe: At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)

Population: PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

Blood samples were collected for the measurement of cisplatin concentrations.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=1 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=8 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion (Ceoi) of Cisplatin	—	3.3 mcg/mL Standard Deviation NA NA indicates that the standard deviation was not estimable for only 1 participant.	—	3.9 mcg/mL Standard Deviation 1.0	—	—

SECONDARY outcome

Timeframe: At end of infusion on Day 1 of Cycle 1 (cycle duration=3 weeks)

Population: PK population included all participants from the all-treated population with at least 1 post-baseline PK concentration with adequate documentation of dosing and sampling dates and times. Only those participants with data collected at the specified timepoint are reported. Data is reported for Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

Blood samples were collected for the measurement of carboplatin concentrations.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=4 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=1 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=10 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=2 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Triplet and Quadruplet Cohorts: Total Plasma Concentration Observed at the End of Infusion of Carboplatin	—	33.4 mcg/mL Standard Deviation 5.0	20.8 mcg/mL Standard Deviation NA NA indicates that the standard deviation was not estimable for only 1 participant.	36.7 mcg/mL Standard Deviation 17.4	29.7 mcg/mL Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet)

Population: ATA population included all participants from the all-treated population with at least 1 post-baseline ATA result (negative, positive, or inconclusive). Data is reported for Part A (doublet cohort), Part B (triplet cohort) and Part C (quadruplet cohort) at both tusamitamab ravtansine doses.

Blood samples were collected to assess the presence of treatment-emergent ATA against tusamitamab ravtansine. ATA incidence was defined as the number of participants found to have treatment-emergent ATA response during the study.

Outcome measures

Outcome measures
Measure	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=19 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 Participants In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 Participants In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=20 Participants In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
All Cohorts: Number of Participants With Treatment-emergent Anti-Therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine	2 Participants	9 Participants	1 Participants	3 Participants	0 Participants	8 Participants

Adverse Events

Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab

Serious events: 9 serious events

Other events: 22 other events

Deaths: 5 deaths

Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 2 deaths

Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed

Serious events: 11 serious events

Other events: 19 other events

Deaths: 11 deaths

Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 participants at risk In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 participants at risk In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 participants at risk In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 participants at risk In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=22 participants at risk In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 participants at risk In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Infections and infestations Vascular Device Infection	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Meninges	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Pneumonia	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Pneumonia Aspiration	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Septic Shock	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Urinary Tract Infection	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Cardiac disorders Myocarditis	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Colitis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Dysphagia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Nausea	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Oesophageal Fistula	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Vomiting	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Hepatobiliary disorders Cholestasis	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Hepatobiliary disorders Hepatic Cytolysis	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Hepatobiliary disorders Immune-Mediated Hepatitis	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Asthenia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Disease Progression	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders General Physical Health Deterioration	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Non-Cardiac Chest Pain	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	100.0% 1/1 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Pyrexia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Sudden Death	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Investigations Alanine Aminotransferase Increased	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Femoral Neck Fracture	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Toxicity To Various Agents	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.

Other adverse events

Other adverse events
Measure	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab n=23 participants at risk In Part A (doublet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab n=2 participants at risk In Part A (doublet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 and then Q3W until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=6 participants at risk In Part B (triplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin n=1 participants at risk In Part B (triplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 150 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=22 participants at risk In Part C (quadruplet cohort), participants received tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 150 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.	Tusamitamab Ravtansine 170 mg/m^2 + Pembrolizumab + Cisplatin/Carboplatin + Pemetrexed n=3 participants at risk In Part C (quadruplet cohort), participants received tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and either cisplatin 75 mg/m\^2 or carboplatin AUC 5 via IV infusion on Day 1 of the first 4 cycles (each cycle was 3 weeks), and then tusamitamab ravtansine 170 mg/m\^2 along with pembrolizumab 200 mg and pemetrexed 500 mg/m\^2 via IV infusion on Day 1 of subsequent cycles until confirmed disease progression, unacceptable toxicity, new anticancer therapy initiation, death, or the participant's or Investigator's decision to stop the treatment.
Infections and infestations Nasopharyngitis	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Purulence	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Respiratory Tract Infection	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Respiratory Tract Infection Viral	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Urinary Tract Infection	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Infections and infestations Viral Infection	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Blood and lymphatic system disorders Anaemia	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Blood and lymphatic system disorders Anaemia Megaloblastic	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Blood and lymphatic system disorders Neutropenia	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Blood and lymphatic system disorders Thrombocytopenia	4.3% 1/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Endocrine disorders Hyperthyroidism	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Endocrine disorders Hypothyroidism	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Endocrine disorders Immune-Mediated Hypothyroidism	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Psychiatric disorders Anxiety	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Psychiatric disorders Depressed Mood	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Psychiatric disorders Insomnia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Dysaesthesia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Headache	8.7% 2/23 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Monoparesis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Neuropathy Peripheral	26.1% 6/23 • Number of events 7 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	40.9% 9/22 • Number of events 12 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Paraesthesia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Nervous system disorders Polyneuropathy	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Cataract	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Conjunctivitis Allergic	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Dry Eye	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Keratitis	43.5% 10/23 • Number of events 18 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Keratopathy	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	100.0% 1/1 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Lacrimation Increased	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Punctate Keratitis	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Vision Blurred	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	22.7% 5/22 • Number of events 5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Visual Acuity Reduced	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	66.7% 2/3 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Eye disorders Visual Impairment	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Ear and labyrinth disorders Tinnitus	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Vascular disorders Hyperaemia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Vascular disorders Hypertension	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Vascular disorders Hypertensive Crisis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Vascular disorders Hypotension	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	27.3% 6/22 • Number of events 6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Malignant Pleural Effusion	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Productive Cough	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Respiratory, thoracic and mediastinal disorders Sputum Discoloured	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Abdominal Pain	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Constipation	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	27.3% 6/22 • Number of events 9 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Diarrhoea	17.4% 4/23 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	45.5% 10/22 • Number of events 11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Dry Mouth	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Dysphagia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Gastritis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Haematochezia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 11/22 • Number of events 19 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	100.0% 3/3 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Odynophagia	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Tongue Blistering	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Gastrointestinal disorders Vomiting	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	40.9% 9/22 • Number of events 10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Rash	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Arthralgia	17.4% 4/23 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	27.3% 6/22 • Number of events 11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Back Pain	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 2/6 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Renal and urinary disorders Nephritis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Renal and urinary disorders Renal Failure	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	18.2% 4/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Reproductive system and breast disorders Vulvovaginal Pruritus	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Asthenia	34.8% 8/23 • Number of events 8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	66.7% 4/6 • Number of events 8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	59.1% 13/22 • Number of events 19 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Chills	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Device Related Thrombosis	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Fatigue	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	50.0% 1/2 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Mucosal Inflammation	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Non-Cardiac Chest Pain	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Oedema Peripheral	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	27.3% 6/22 • Number of events 10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
General disorders Pyrexia	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Investigations Aspartate Aminotransferase Increased	4.3% 1/23 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	4.5% 1/22 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	33.3% 1/3 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Investigations Blood Creatinine Increased	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/6 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	13.6% 3/22 • Number of events 3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Investigations Weight Decreased	8.7% 2/23 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	9.1% 2/22 • Number of events 4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.
Product Issues Device Material Opacification	0.00% 0/23 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	16.7% 1/6 • Number of events 1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/22 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.	0.00% 0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment, approximately 162.4 weeks (doublet), 117 weeks (triplet), and 143.9 weeks (quadruplet). All-cause mortality was collected from first dose of study treatment (Day 1) up to end of the study visit, approximately 198 weeks. Analysis was performed on all-treated population.

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