Trial Outcomes & Findings for BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma (NCT NCT03762018)

NCT ID: NCT03762018

Last Updated: 2026-05-14

Results Overview

Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

From randomization until death from any cause, up to 52 months.

Results posted on

2026-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Overall Study STARTED	200	200
Overall Study Received at least one dose of trial treatment	198	200
Overall Study On treatment	8	4
Overall Study Treatment failures	192	196
Overall Study Never started treatment	2	0
Overall Study COMPLETED	51	48
Overall Study NOT COMPLETED	149	152

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Overall Study Death	145	150
Overall Study Withdrawal/Lost to follow-up	4	2

Baseline Characteristics

BEAT-meso: Bevacizumab and Atezolizumab in Malignant Pleural Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Total n=400 Participants Total of all reporting groups
Sex: Female, Male Male	160 Participants n=1512 Participants	156 Participants n=504 Participants	316 Participants n=2016 Participants
Race/Ethnicity, Customized White	199 Participants n=1512 Participants	200 Participants n=504 Participants	399 Participants n=2016 Participants
Age, Continuous	70.7 years n=1512 Participants	70.1 years n=504 Participants	70.4 years n=2016 Participants
Sex: Female, Male Female	40 Participants n=1512 Participants	44 Participants n=504 Participants	84 Participants n=2016 Participants
Race/Ethnicity, Customized Black	1 Participants n=1512 Participants	0 Participants n=504 Participants	1 Participants n=2016 Participants
Smoking status Current smoker	15 Participants n=1512 Participants	11 Participants n=504 Participants	26 Participants n=2016 Participants
Smoking status Former smoker	99 Participants n=1512 Participants	99 Participants n=504 Participants	198 Participants n=2016 Participants
Smoking status Never smoked	86 Participants n=1512 Participants	90 Participants n=504 Participants	176 Participants n=2016 Participants
ECOG Performance Status 0	80 Participants n=1512 Participants	61 Participants n=504 Participants	141 Participants n=2016 Participants
ECOG Performance Status 1	119 Participants n=1512 Participants	139 Participants n=504 Participants	258 Participants n=2016 Participants
ECOG Performance Status Unknown/Missing	1 Participants n=1512 Participants	0 Participants n=504 Participants	1 Participants n=2016 Participants
Stage IV	43 Participants n=1512 Participants	41 Participants n=504 Participants	84 Participants n=2016 Participants
Stage Other	157 Participants n=1512 Participants	159 Participants n=504 Participants	316 Participants n=2016 Participants
Histology Epithelioid	157 Participants n=1512 Participants	154 Participants n=504 Participants	311 Participants n=2016 Participants
Histology Non pure epithelioid	43 Participants n=1512 Participants	46 Participants n=504 Participants	89 Participants n=2016 Participants
Asbestos exposure Yes	84 Participants n=1512 Participants	89 Participants n=504 Participants	173 Participants n=2016 Participants
Asbestos exposure Possible	51 Participants n=1512 Participants	58 Participants n=504 Participants	109 Participants n=2016 Participants
Asbestos exposure No	48 Participants n=1512 Participants	33 Participants n=504 Participants	81 Participants n=2016 Participants
Asbestos exposure Unknown/Missing	17 Participants n=1512 Participants	20 Participants n=504 Participants	37 Participants n=2016 Participants
PD-L1 TPS% <1	117 Participants n=1512 Participants	98 Participants n=504 Participants	215 Participants n=2016 Participants
PD-L1 TPS% 1-49	56 Participants n=1512 Participants	66 Participants n=504 Participants	122 Participants n=2016 Participants
PD-L1 TPS% ≥50	21 Participants n=1512 Participants	26 Participants n=504 Participants	47 Participants n=2016 Participants
PD-L1 TPS% Unknown/Missing	6 Participants n=1512 Participants	10 Participants n=504 Participants	16 Participants n=2016 Participants
EORTC prognostic score Good prognosis	146 Participants n=1512 Participants	134 Participants n=504 Participants	280 Participants n=2016 Participants
EORTC prognostic score Poor prognosis	54 Participants n=1512 Participants	66 Participants n=504 Participants	120 Participants n=2016 Participants
Mesothelioma risk score (MRS) 0-Favorable	72 Participants n=1512 Participants	64 Participants n=504 Participants	136 Participants n=2016 Participants
Mesothelioma risk score (MRS) 1-Intermediate	66 Participants n=1512 Participants	63 Participants n=504 Participants	129 Participants n=2016 Participants
Mesothelioma risk score (MRS) 2-Poor	62 Participants n=1512 Participants	73 Participants n=504 Participants	135 Participants n=2016 Participants
Medical history Yes	189 Participants n=1512 Participants	187 Participants n=504 Participants	376 Participants n=2016 Participants
Medical history No	11 Participants n=1512 Participants	13 Participants n=504 Participants	24 Participants n=2016 Participants

PRIMARY outcome

Timeframe: From randomization until death from any cause, up to 52 months.

Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)

Overall survival is defined as the time from the date of randomisation until death from any cause. Data for patients who are not reported as having died at the date of analysis will be censored at the date when they were last known to be alive. Data for patients without post-baseline information will be censored at the date of randomization (plus 1 day).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Overall Survival (OS)	20.5 months Interval 17.5 to 23.3	18.1 months Interval 15.7 to 20.9

SECONDARY outcome

Timeframe: From randomization until documented progression (PD) according to mRECIST v1.1 or death from any cause (whichever occurred first), up to 52 months.

Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)

PFS is defined as the time from the date of randomisation until documented progression (according to the mRECIST v1.1) or death, if progression is not documented. Censoring (for participants without a PFS/death event) will occur at the date of last tumour assessment. Patients without a post-baseline tumour assessment will be censored at the date of randomization (plus 1 day).

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Progression-free Survival (PFS) According to the mRECIST v1.1	9.2 months Interval 8.1 to 10.9	7.6 months Interval 6.9 to 8.3

SECONDARY outcome

Timeframe: From randomization to termination of trial treatment, up to 52 months.

Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)

Objective Response Rate (ORR) is defined as the percentage of patients that achieve a best overall response \[complete response (CR) or partial response (PR)\] evaluated according to the mRECIST v1.1 across all post-randomization time-points until the end of protocol treatment. Confirmation of response will not be required.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Objective Response Rate (ORR)	110 Participants	98 Participants

SECONDARY outcome

Timeframe: From randomization to 24 weeks; participants assessed for treatment response status at 24 weeks.

Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)

Disease Control (DC) is defined as complete or partial response, or disease stabilisation at 24 weeks (+/- 10 days). Patients with no available scan at this time period, but with scan performed before 24 weeks - 10 days and scan performed after 24 weeks + 10 days showing disease control, will be considered as disease control.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Disease Control (DC) at 24 Weeks	134 Participants	115 Participants

SECONDARY outcome

Timeframe: From randomization until discontinuation of protocol treatment for any reason, up to 52 months.

Population: Efficacy population (Intention-To-Treat cohort of all randomised patients)

Time to Treatment Failure (TTF) is defined as the time from the date of randomisation to discontinuation of protocol treatment for any reason (including progression of disease, death, discontinuation of at least one of the drugs consisting the treatment combination due to any reason, such as toxicity or refusal). Censoring will occur at the last follow-up date.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=200 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=200 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Time to Treatment Failure (TTF)	6.5 months Interval 5.6 to 7.4	6.5 months Interval 5.7 to 7.0

SECONDARY outcome

Timeframe: From documentation of objective response until the date of first documented progression/relapse or death, up to 52 months.

Population: Patients with objective response

Duration of Response (DoR) is defined as the interval from the date of first documentation of objective response (complete response or partial response, according to the mRECIST v1.1) to the date of first documented progression/relapse or death.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=110 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=98 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Duration of Response (DoR)	8.2 months Interval 6.8 to 9.7	5.6 months Interval 4.8 to 7.0

SECONDARY outcome

Timeframe: From randomization until 12 weeks after treatment start, up to 52 months.

Population: QoL cohort: all randomized patients who had baseline assessment and at least one on-treatment post-baseline score for any LCSS-Meso item

QoL is assessed by the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) an 8-item questionnaire including five symptoms associated with mesothelioma (i.e., appetite loss, fatigue, cough, dyspnoea, and pain) and three items addressing symptomatic distress, normal activity, and global QoL. All items are measured by visual analogue scales (VAS) using 100-mm lines to assess the intensity of each item based on patient responses within the time frame of the past day. Each item is assigned an individual score corresponding to the length of the line representing intensity as marked by the patient on a 0-100 scale, with 0 as the best rating (i.e., no symptom distress, no interference with activity level, or best possible health-related quality of life) and 100-mm as the worst rating. The primary QoL endpoint is the change in the LCSS total score (average of all 8 items) from baseline to 12 weeks after treatment start.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=157 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=155 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Quality of Life (QoL)	0.4 units on a scale Interval -2.3 to 3.0	2.1 units on a scale Interval -0.4 to 4.7

SECONDARY outcome

Timeframe: From randomization to 90 days after the last dose of protocol treatment, up to 52 months.

Population: Safety population, patients who received at least 1 dose of treatment: 198 in ABC/200 in BC. But, one patient assigned in the BC arm received ABC. For the safety analysis, the patient is evaluated according to the treatment received irrespective of the allocated treatment at randomization (safety population: 199 in each arm). Of note, in the next section, all-cause mortality was assessed for all randomized, while serious adverse events/adverse events were assessed for the safety population.

Adverse events, according to CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=199 Participants Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=199 Participants Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Adverse Events Experienced AE/SAE · Experienced AE/SAE	197 Participants	197 Participants
Adverse Events Experienced SAE · Experienced AE/SAE	92 Participants	67 Participants

Adverse Events

Atezolizumab Plus Bevacizumab Plus Chemotherapy

Serious events: 92 serious events

Other events: 197 other events

Deaths: 145 deaths

Bevacizumab Plus Chemotherapy

Serious events: 67 serious events

Other events: 197 other events

Deaths: 150 deaths

Serious adverse events

Serious adverse events
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=199 participants at risk Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=199 participants at risk Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
Blood and lymphatic system disorders Anemia	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Blood and lymphatic system disorders Febrile neutropenia	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Blood and lymphatic system disorders Immune thrombo-cytopenic purpura	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Blood and lymphatic system disorders Pancytopenia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Asystole	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Atrial fibrillation	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Chest pain - cardiac	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Heart failure	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Myocardial infarction	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Myocarditis	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Supraventricular tachycardia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Cardiac disorders Ventricular arrhythmia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Endocrine disorders Adrenal insufficiency	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Endocrine disorders Hypophysitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Endocrine disorders Hypothyroidism	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Abdominal pain	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Anal fistula	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Colitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Colonic obstruction	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Colonic perforation	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Constipation	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Diarrhea	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Diverticulitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Duodenal ulcer	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Dysphagia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Gastric ulcer	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Ileus	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Pancreatitis	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Proctitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Rectal perforation	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Typhlitis	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Vomiting	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Death NOS	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Fever	4.0% 8/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	2.0% 4/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Flu like symptoms	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders General clinical conditions worsening	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders General status alteration	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Generalized edema	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Lumbar spine joint range of motion decreased	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Malaise	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Hepatobiliary disorders Cholecystitis	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Hepatobiliary disorders Hepatitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Immune system disorders Allergic reaction	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Immune system disorders Autoimmune disorder	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Bacteremia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations COVID-19 infection	3.5% 7/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Device related infection	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Fungemia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Infection (unknown source)	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Lung infection	4.5% 9/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Pleural infection	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Port-a-cath infection	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Sepsis	4.0% 8/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Skin infection	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Upper respiratory infection	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Urinary tract infection	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Wound infection	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Injury, poisoning and procedural complications Fall	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Injury, poisoning and procedural complications Infusion related reaction	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Aspartate aminotransferase increased	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Neutrophil count decreased	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Platelet count decreased	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Anorexia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Dehydration	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hypoglycemia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hypomagnesemia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hyponatremia	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Myositis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukemia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate adenocarcinoma	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell neuroendocrine carcinoma	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urinary bladder nodule (left trigone region)	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Cognitive disturbance	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Headache	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Intracranial hemorrhage	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Neuralgia	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Peripheral sensory neuropathy	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Seizure	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Syncope	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Psychiatric disorders Confusion	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Acute kidney injury	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Hematuria	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Nephritis	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Renal biopsy	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Renal toxicity	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease (COPD)	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Dyspnea	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	2.0% 4/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Organized pneumonia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Bullous dermatitis	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Skin ulceration	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Surgical and medical procedures Elective surgery popliteal aneurysm	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Arterial thromboembolism	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Hematoma	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Hypertension	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Hypotension	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Peripheral ischemia	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Superficial thrombophlebitis	0.00% 0/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	0.50% 1/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Thromboembolic event	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).

Other adverse events

Other adverse events
Measure	Atezolizumab Plus Bevacizumab Plus Chemotherapy n=199 participants at risk Atezolizumab 1200mg intravenously on day 1 every 3 weeks plus bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks	Bevacizumab Plus Chemotherapy n=199 participants at risk Bevacizumab 15mg/kg intravenously on day 1 every 3 weeks plus 4-6 cycles of carboplatin AUC 5 plus pemetrexed 500mg/m\^2 intravenously on day 1 every 3 weeks
General disorders Fatigue	56.8% 113/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	55.3% 110/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Nausea	42.2% 84/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	46.7% 93/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Constipation	41.7% 83/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	40.7% 81/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Blood and lymphatic system disorders Anemia	36.7% 73/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	35.7% 71/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Hypertension	36.7% 73/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	31.2% 62/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Neutrophil count decreased	32.7% 65/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	28.6% 57/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Anorexia	29.6% 59/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	27.1% 54/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Epistaxis	28.1% 56/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	28.1% 56/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Mucositis oral	32.7% 65/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	23.6% 47/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Diarrhea	28.6% 57/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	20.1% 40/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Dyspnea	22.1% 44/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	25.6% 51/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Non-cardiac chest pain	15.6% 31/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	18.1% 36/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Platelet count decreased	20.6% 41/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	13.1% 26/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Cough	16.6% 33/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	16.6% 33/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Creatinine increased	19.6% 39/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Fever	21.6% 43/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.5% 17/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Pruritus	17.6% 35/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Vomiting	15.1% 30/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	14.6% 29/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Renal and urinary disorders Proteinuria	16.6% 33/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Rash maculo-papular	17.6% 35/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	9.5% 19/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Alanine aminotransferase increased	13.1% 26/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	12.6% 25/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Arthralgia	12.6% 25/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Aspartate aminotransferase increased	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	11.1% 22/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Headache	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	11.1% 22/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hypomagnesemia	9.5% 19/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	13.6% 27/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Dysgeusia	13.6% 27/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.5% 17/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Eye disorders Watering eyes	8.5% 17/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	12.6% 25/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Back pain	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.5% 17/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Lung infection	7.5% 15/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	12.6% 25/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Abdominal pain	11.6% 23/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.0% 16/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations COVID-19 infection	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Edema limbs	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	7.5% 15/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Psychiatric disorders Insomnia	9.5% 19/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.0% 16/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
General disorders Pain	7.0% 14/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Vascular disorders Thromboembolic event	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations GGT increased	7.0% 14/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	7.5% 15/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Endocrine disorders Hypothyroidism	12.1% 24/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Pain in extremity	9.0% 18/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Serum amylase increased	8.0% 16/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Urinary tract infection	10.6% 21/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	4.0% 8/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	8.5% 17/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations Weight loss	7.5% 15/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Dry skin	9.0% 18/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	3.5% 7/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hyperglycemia	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Investigations White blood cell decreased	7.0% 14/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	4.5% 9/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Dizziness	4.0% 8/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Hoarseness	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	4.5% 9/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Infections and infestations Conjunctivitis	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Eye disorders Dry eye	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	3.5% 7/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Dysphagia	5.0% 10/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	4.5% 9/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Flank pain	5.0% 10/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	4.5% 9/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Gastrointestinal disorders Gastroesophageal reflux disease	4.0% 8/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Injury, poisoning and procedural complications Infusion related reaction	8.0% 16/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Chest wall pain	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Psychiatric disorders Depression	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Blood and lymphatic system disorders Febrile neutropenia	6.0% 12/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	2.5% 5/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Musculoskeletal and connective tissue disorders Myalgia	7.5% 15/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Rash acneiform	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Endocrine disorders Hyperthyroidism	6.5% 13/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.0% 6/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	5.0% 10/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Skin and subcutaneous tissue disorders Hyperhidrosis	5.0% 10/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.5% 3/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Metabolism and nutrition disorders Hyponatremia	5.5% 11/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).
Nervous system disorders Peripheral sensory neuropathy	5.0% 10/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).	1.0% 2/199 • Adverse events were assessed from randomization until 90 days after the last dose of protocol treatment, up to 52 months. Adverse event (AE) is defined as any untoward medical occurrence that occurs from randomization until 90 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication. Adverse events are classified according to CTCAE version 5.0 and assessed in safety population (patients who received at least 1 dose of trial treatment: 199 in each arm). Of note, all-cause mortality was assessed for all randomized (200 in each arm).

Additional Information

Dr. Heidi Roschitzki, PhD

ETOP IBCSG Partners Foundation

Phone: +41 31 511 94 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place