Trial Outcomes & Findings for Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (NCT NCT03626545)

Last Updated: 2023-08-21

Results Overview

Percentage of participants with DLTs. A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 42 days of docetaxel and canakinumab treatment.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

245 participants

Primary outcome timeframe

During the first 42 days of dosing

Results posted on

2023-08-21

Participant Flow

The Safety run-in (Part 1) was conducted in 6 centers across 4 countries and the Randomized part (Part 2) was conducted in 85 centers across 26 countries.

In the randomized part, a total of 352 subjects were screened. 237 subjects completed the screening phase and were randomized in a 1:1 ratio to treatment with either canakinumab plus docetaxel or placebo plus docetaxel. Three randomized subjects in the placebo plus docetaxel group were not treated

Participant milestones

Participant milestones
Measure	Safety run-in Part: Canakinumab+Docetaxel Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Canakinumab + Docetaxel Participants were randomized to receive canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Overall Study STARTED	8	120	117
Overall Study Treated	8	120	114
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	8	120	117

Reasons for withdrawal

Reasons for withdrawal
Measure	Safety run-in Part: Canakinumab+Docetaxel Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Canakinumab + Docetaxel Participants were randomized to receive canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Overall Study Progressive disease	3	82	85
Overall Study Adverse Event	3	13	10
Overall Study Physician Decision	1	18	14
Overall Study Subject Decision	0	5	5
Overall Study Death	1	1	1
Overall Study Protocol Deviation	0	1	1
Overall Study Guardian Decision	0	0	1

Baseline Characteristics

Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Canakinumab + Docetaxel n=120 Participants Participants were randomized to receive canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Total n=245 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 4.19 • n=5 Participants	63.4 Years STANDARD_DEVIATION 9.13 • n=7 Participants	62.2 Years STANDARD_DEVIATION 10.05 • n=5 Participants	62.6 Years STANDARD_DEVIATION 9.54 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	38 Participants n=7 Participants	32 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	82 Participants n=7 Participants	85 Participants n=5 Participants	173 Participants n=4 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	91 Participants n=7 Participants	83 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	22 Participants n=7 Participants	27 Participants n=5 Participants	49 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: During the first 42 days of dosing

Population: Participants in the safety run-in part to whom study treatment was assigned, who received at least one dose of any study treatment (including incomplete infusion) and met the minimum exposure criterion and have sufficient safety evaluations, or experienced a DLT during the first 42 days of dosing

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=7 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)	1 Participants	—	—

PRIMARY outcome

Timeframe: From randomization until death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approximately (approx.) 18 months)

Population: Full Analysis Set (FAS) in randomized part: All participants to whom study treatment was assigned by randomization.

OS is defined as the time from randomization to date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. If a subject was not known to have died, then OS was censored at the latest date the subject was known to be alive (on or before the cut-off date).

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Overall Survival (OS)	10.55 Months Interval 8.15 to 12.39	11.30 Months Interval 8.54 to 13.8	—

SECONDARY outcome

Timeframe: Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)

Population: FAS in Safety run-in part: all participants to whom study treatment was assigned and who received at least one dose of any study treatment (including incomplete infusion) FAS in Randomized part: all participants to whom study treatment was assigned by randomization

ORR is defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. The 95% confidence intervals (CIs) were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=120 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Overall Response Rate (ORR)	0.0 Percentage of participants NA: Not estimable because no participants had best overall response of CR or PR	15.0 Percentage of participants Interval 9.1 to 22.7	13.7 Percentage of participants Interval 8.0 to 21.3

SECONDARY outcome

Timeframe: From first documented response of CR or PR to date of first documented progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 10 months for the safety run-in and 18 months for the randomized)

Population: FAS in Safety run-in part: all participants to whom study treatment was assigned and who received at least one dose of any study treatment (including incomplete infusion) for whom best overall response is CR or PR FAS in Randomized part: all participants to whom study treatment was assigned by randomization for whom best overall response is CR or PR

DOR is defined as the time from first documented response of CR or PR to date of first documented progression or death, by investigator's assessment according to RECIST 1.1 criteria. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=18 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel n=16 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Duration of Response (DOR)	—	4.14 Months Interval 2.89 to 11.17	5.42 Months Interval 4.17 to Not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 10 months for the safety run-in part and 18 months for the randomized part)

DCR is defined as the percentage of participants with CR or PR or with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. The 95% CIs were computed using Clopper and Pearson method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=120 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Disease Control Rate (DCR)	62.5 Percentage of participants Interval 24.5 to 91.5	65.8 Percentage of participants Interval 56.6 to 74.2	61.5 Percentage of participants Interval 52.1 to 70.4

SECONDARY outcome

Timeframe: From randomization until disease progression, death or final analysis data cutoff date (08-Jan-2021) whichever comes first (assessed up to approx. 18 months)

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization

PFS is defined as the time from randomization to the date of the first documented radiological progression by investigator assessment according to RECIST 1.1 response criteria or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. If a participant did not have disease progression or die at the analysis cut-off date, PFS was censored at the date of last adequate tumor assessment.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Progression-Free Survival (PFS)	4.17 Months Interval 2.96 to 5.42	4.21 Months Interval 3.06 to 5.13	—

SECONDARY outcome

Timeframe: From randomization until first documented response or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approx. 18 months)

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization

TTR is defined as the time from the date of randomization to the date of first documented response of either CR or PR, by investigator's assessment according to RECIST 1.1 criteria. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated for each treatment group. Subjects without a confirmed CR or PR at the time of the analysis cut-off date were censored at the study-maximum follow-up time for subjects with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for subjects without a PFS event. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Time to Response (TTR)	NA Months NA: Not evaluable due to the low number of participants with events	NA Months NA: Not evaluable due to the low number of participants with events	—

SECONDARY outcome

Timeframe: From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization

The EORTC QLQ-LC13 comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie. hair loss, neuropathy, sore mouth, and dysphagia). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTD for chest pain, cough and dyspnea is defined as the time from randomization to the date of event, which is defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.\<10 points was observed or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurs earlier). If a subject did not have an event, TTD was censored at the last adequate assessment.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Time to Definitive 10-point Deterioration (TTD) Symptom Scores of Chest Pain, Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Lung Cancer (LC13) Questionnaire Chest Pain	7.23 Months Interval 4.96 to NA: Upper limit was not reached due to the insufficient number of participants with events	13.14 Months Interval 7.06 to NA: Upper limit was not reached due to the insufficient number of participants with events	—
Randomized Part: Time to Definitive 10-point Deterioration (TTD) Symptom Scores of Chest Pain, Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Lung Cancer (LC13) Questionnaire Cough	7.23 Months Interval 5.09 to NA: Upper limit was not reached due to the insufficient number of participants with events	13.14 Months Interval 7.85 to NA: Upper limit was not reached due to the insufficient number of participants with events	—
Randomized Part: Time to Definitive 10-point Deterioration (TTD) Symptom Scores of Chest Pain, Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) Lung Cancer (LC13) Questionnaire Dyspnea	3.45 Months Interval 2.14 to 4.83	4.27 Months Interval 2.63 to 5.65	—

SECONDARY outcome

Timeframe: From baseline through final analysis data cutoff date of 08-Jan-2021 (assessed up to approx. 18 months)

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization

The EORTC QLQ-C30 includes 5 functional scales (physical,role,cognitive,emotional and social), 3 symptom scales (fatigue,pain and nausea/vomiting), a GHS/QoL scale, and 6 single items (constipation,diarrhea,insomnia,shortness of breath,appetite loss and financial difficulties). For each scale and single-item, scores range between 0 and 100. A high score for functional scales/ GHS/QoL represents better functioning or QoL, a high score for symptom scales/single items represents significant symptomatology. TTD in GHS/QoL, shortness of breath and pain is defined as the time from randomization to the date of event, defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold i.e.\<10 points was observed or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurs earlier). If a subject did not have an event, TTD was censored at the last adequate assessment.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Time to Definitive 10-point Deterioration in Global Health Status (GHS)/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire GHS/QOL	4.83 Months Interval 3.48 to 6.97	7.16 Months Interval 4.8 to 13.14	—
Randomized Part: Time to Definitive 10-point Deterioration in Global Health Status (GHS)/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Shortness of breath	6.57 Months Interval 4.6 to 7.89	5.78 Months Interval 4.27 to NA: Upper limit was not reached due to the insufficient number of participants with events	—
Randomized Part: Time to Definitive 10-point Deterioration in Global Health Status (GHS)/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Pain	6.05 Months Interval 4.47 to 7.72	8.54 Months Interval 4.27 to 10.38	—

SECONDARY outcome

Timeframe: Baseline, every 3 weeks from Week 3 until end of treatment, every 6 or 12 weeks post-treatment until progression (post-treatment efficacy visits), 7 and 28 days post progression through final analysis cutoff date of 08Jan2021 (up to approx. 18 months)

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization. Number analyzed represents participants with data available at the specified data points

The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and 6 single items (constipation, diarrhea, insomnia, dyspnoea, appetite loss and financial difficulties). For each scale and item, scores range 0-100. A high score for functional scales/QoL represents better functioning/QoL; a high score for symptom scales and items represents significant symptomatology. Changes from baseline in QoL, shortness of breath and pain scores are presented. For QoL, a negative change from baseline indicates improvement; for shortness of breath and pain a positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 36	-4.5 Score on a scale Standard Deviation 15.97	3.3 Score on a scale Standard Deviation 27.06	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 39	-5.8 Score on a scale Standard Deviation 18.02	1.2 Score on a scale Standard Deviation 28.28	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 42	-9.2 Score on a scale Standard Deviation 16.41	2.8 Score on a scale Standard Deviation 29.15	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 45	-3.6 Score on a scale Standard Deviation 16.57	-3.5 Score on a scale Standard Deviation 22.32	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 48	-8.3 Score on a scale Standard Deviation 19.72	-13.9 Score on a scale Standard Deviation 13.82	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 51	-8.3 Score on a scale Standard Deviation 16.67	-6.7 Score on a scale Standard Deviation 21.80	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 60	-8.3 Score on a scale Standard Deviation 22.05	2.1 Score on a scale Standard Deviation 38.71	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 3	-0.5 Score on a scale Standard Deviation 18.34	1.8 Score on a scale Standard Deviation 21.51	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 6	-3.3 Score on a scale Standard Deviation 17.48	1.4 Score on a scale Standard Deviation 22.19	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 9	-2.7 Score on a scale Standard Deviation 20.04	-0.4 Score on a scale Standard Deviation 23.50	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 12	-7.4 Score on a scale Standard Deviation 19.75	2.5 Score on a scale Standard Deviation 22.14	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 15	-2.9 Score on a scale Standard Deviation 19.85	-4.2 Score on a scale Standard Deviation 22.60	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 18	-3.9 Score on a scale Standard Deviation 22.75	2.8 Score on a scale Standard Deviation 24.69	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 21	-3.5 Score on a scale Standard Deviation 25.31	-4.2 Score on a scale Standard Deviation 27.25	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 24	-3.6 Score on a scale Standard Deviation 16.08	-0.7 Score on a scale Standard Deviation 24.90	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 27	-4.7 Score on a scale Standard Deviation 16.25	-2.2 Score on a scale Standard Deviation 26.51	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 30	-3.7 Score on a scale Standard Deviation 19.43	-5.7 Score on a scale Standard Deviation 30.31	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 33	-3.2 Score on a scale Standard Deviation 15.79	0.4 Score on a scale Standard Deviation 31.82	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 63	-5.6 Score on a scale Standard Deviation 17.35	2.8 Score on a scale Standard Deviation 4.81	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 66	8.3 Score on a scale Standard Deviation 11.79	-8.3 Score on a scale Standard Deviation 11.79	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 69	16.7 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	0.0 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 72	—	-8.3 Score on a scale Standard Deviation 11.79	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 75	—	-16.7 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 78	—	-16.7 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: post treatment efficacy visit 1	-16.7 Score on a scale Standard Deviation 11.79	5.6 Score on a scale Standard Deviation 9.62	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: post treatment efficacy visit 2	-16.7 Score on a scale Standard Deviation 16.67	16.7 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: post treatment efficacy visit 3	—	-8.3 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: post treatment efficacy visit 5	—	25.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: 7 days post disease progression	-7.5 Score on a scale Standard Deviation 26.65	-4.6 Score on a scale Standard Deviation 22.11	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: 28 days post disease progression	-3.7 Score on a scale Standard Deviation 29.60	-7.8 Score on a scale Standard Deviation 20.08	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 3	31.2 Score on a scale Standard Deviation 28.30	31.7 Score on a scale Standard Deviation 30.02	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 6	7.3 Score on a scale Standard Deviation 24.99	4.0 Score on a scale Standard Deviation 28.06	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 9	6.7 Score on a scale Standard Deviation 27.13	5.7 Score on a scale Standard Deviation 28.36	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 12	12.2 Score on a scale Standard Deviation 25.61	4.4 Score on a scale Standard Deviation 29.73	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 15	7.8 Score on a scale Standard Deviation 21.69	7.3 Score on a scale Standard Deviation 29.58	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 18	8.5 Score on a scale Standard Deviation 26.54	3.5 Score on a scale Standard Deviation 30.93	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 21	34.2 Score on a scale Standard Deviation 29.71	29.8 Score on a scale Standard Deviation 27.72	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 24	4.8 Score on a scale Standard Deviation 21.61	6.9 Score on a scale Standard Deviation 32.60	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 27	13.0 Score on a scale Standard Deviation 24.08	-1.2 Score on a scale Standard Deviation 36.38	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 30	16.7 Score on a scale Standard Deviation 20.61	5.3 Score on a scale Standard Deviation 38.10	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 33	17.9 Score on a scale Standard Deviation 22.01	-1.7 Score on a scale Standard Deviation 39.70	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 36	9.1 Score on a scale Standard Deviation 21.56	-2.2 Score on a scale Standard Deviation 32.04	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 39	33.3 Score on a scale Standard Deviation 27.22	40.5 Score on a scale Standard Deviation 26.73	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 42	23.3 Score on a scale Standard Deviation 27.44	-6.7 Score on a scale Standard Deviation 31.37	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 45	9.5 Score on a scale Standard Deviation 31.71	8.3 Score on a scale Standard Deviation 40.51	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 48	22.2 Score on a scale Standard Deviation 34.43	3.7 Score on a scale Standard Deviation 26.06	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 51	16.7 Score on a scale Standard Deviation 18.26	0.0 Score on a scale Standard Deviation 22.22	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 54	11.1 Score on a scale Standard Deviation 17.21	9.5 Score on a scale Standard Deviation 37.09	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 57	8.3 Score on a scale Standard Deviation 31.91	20.0 Score on a scale Standard Deviation 38.01	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 60	0.0 Score on a scale Standard Deviation 33.33	16.7 Score on a scale Standard Deviation 43.03	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 63	0.0 Score on a scale Standard Deviation 33.33	0.0 Score on a scale Standard Deviation 33.33	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 66	-16.7 Score on a scale Standard Deviation 23.57	0.0 Score on a scale Standard Deviation 47.14	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 69	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	-16.7 Score on a scale Standard Deviation 70.71	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 72	—	-16.7 Score on a scale Standard Deviation 70.71	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 75	—	33.3 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: Week 78	—	33.3 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: post treatment efficacy visit 1	33.3 Score on a scale Standard Deviation 47.14	33.3 Score on a scale Standard Deviation 33.33	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: post treatment efficacy visit 2	0.0 Score on a scale Standard Deviation 33.33	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: post treatment efficacy visit 3	—	16.7 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: post treatment efficacy visit 5	—	0.00 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: 7 days post disease progression	8.6 Score on a scale Standard Deviation 21.03	8.0 Score on a scale Standard Deviation 29.08	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Shortness of breath: 28 days post disease progression	3.7 Score on a scale Standard Deviation 27.75	15.7 Score on a scale Standard Deviation 29.15	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 3	-5.1 Score on a scale Standard Deviation 21.07	-2.0 Score on a scale Standard Deviation 22.53	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 6	-5.1 Score on a scale Standard Deviation 20.33	-1.6 Score on a scale Standard Deviation 24.07	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 9	-4.1 Score on a scale Standard Deviation 19.33	-3.1 Score on a scale Standard Deviation 21.85	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 12	2.2 Score on a scale Standard Deviation 24.61	-1.4 Score on a scale Standard Deviation 27.32	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 15	-0.7 Score on a scale Standard Deviation 20.81	0.7 Score on a scale Standard Deviation 22.07	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 18	2.3 Score on a scale Standard Deviation 23.34	0.7 Score on a scale Standard Deviation 25.25	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 21	3.3 Score on a scale Standard Deviation 24.52	0.0 Score on a scale Standard Deviation 25.70	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 24	25.2 Score on a scale Standard Deviation 25.36	19.1 Score on a scale Standard Deviation 21.76	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 27	1.4 Score on a scale Standard Deviation 22.42	1.2 Score on a scale Standard Deviation 19.57	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 30	2.8 Score on a scale Standard Deviation 19.17	4.0 Score on a scale Standard Deviation 26.03	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 33	-8.3 Score on a scale Standard Deviation 19.46	6.7 Score on a scale Standard Deviation 21.22	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 36	22.7 Score on a scale Standard Deviation 17.12	26.7 Score on a scale Standard Deviation 23.40	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 39	-10.0 Score on a scale Standard Deviation 21.08	10.7 Score on a scale Standard Deviation 31.08	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 42	-3.3 Score on a scale Standard Deviation 10.54	11.1 Score on a scale Standard Deviation 30.65	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 45	-11.9 Score on a scale Standard Deviation 23.00	15.3 Score on a scale Standard Deviation 30.53	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 48	-5.6 Score on a scale Standard Deviation 22.77	5.6 Score on a scale Standard Deviation 20.41	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 51	2.8 Score on a scale Standard Deviation 24.53	8.3 Score on a scale Standard Deviation 18.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 54	8.3 Score on a scale Standard Deviation 20.41	-2.4 Score on a scale Standard Deviation 32.53	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 57	0.0 Score on a scale Standard Deviation 13.61	6.7 Score on a scale Standard Deviation 19.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 60	16.7 Score on a scale Standard Deviation 16.67	0.0 Score on a scale Standard Deviation 36.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 63	5.6 Score on a scale Standard Deviation 25.46	-16.7 Score on a scale Standard Deviation 16.7	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 66	0.0 Score on a scale Standard Deviation 0.00	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 69	33.3 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	8.3 Score on a scale Standard Deviation 11.79	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 72	—	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 75	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: Week 78	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: post treatment efficacy visit 1	-33.3 Score on a scale Standard Deviation 23.57	-11.1 Score on a scale Standard Deviation 19.25	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: post treatment efficacy visit 2	0.0 Score on a scale Standard Deviation 16.67	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: post treatment efficacy visit 3	—	33.3 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: post treatment efficacy visit 5	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: 7 days post disease progression	1.6 Score on a scale Standard Deviation 18.44	2.3 Score on a scale Standard Deviation 31.41	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire Pain: 28 days post disease progression	9.3 Score on a scale Standard Deviation 23.02	13.7 Score on a scale Standard Deviation 20.61	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 54	-6.9 Score on a scale Standard Deviation 17.01	-4.8 Score on a scale Standard Deviation 31.86	—
Randomized Part: Change From Baseline in GHS/QoL, Shortness of Breath and Pain Scores as Per the EORTC QLQ C30 Questionnaire GHS/QoL: Week 57	-12.5 Score on a scale Standard Deviation 14.43	-8.3 Score on a scale Standard Deviation 36.32	—

SECONDARY outcome

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization. Number analyzed represents participants with data available at the specified data points

The EORTC QLQ-LC13 is a 13-item questionnaire. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher ("worse") level of symptoms. Changes from baseline in chest pain, cough and dyspnea scores are presented. A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 42	6.7 Score on a scale Standard Deviation 26.29	-8.9 Score on a scale Standard Deviation 29.46	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 45	0.0 Score on a scale Standard Deviation 19.25	2.8 Score on a scale Standard Deviation 17.16	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 27	-4.3 Score on a scale Standard Deviation 25.23	-1.2 Score on a scale Standard Deviation 28.47	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 30	-5.6 Score on a scale Standard Deviation 36.60	-4.0 Score on a scale Standard Deviation 26.03	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 48	11.1 Score on a scale Standard Deviation 17.21	3.7 Score on a scale Standard Deviation 20.03	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 51	16.7 Score on a scale Standard Deviation 18.26	-3.3 Score on a scale Standard Deviation 18.92	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 33	2.6 Score on a scale Standard Deviation 16.45	-3.5 Score on a scale Standard Deviation 26.98	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 36	12.1 Score on a scale Standard Deviation 16.82	-6.7 Score on a scale Standard Deviation 28.73	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 39	3.3 Score on a scale Standard Deviation 18.92	-4.8 Score on a scale Standard Deviation 25.68	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 57	-8.3 Score on a scale Standard Deviation 16.67	6.7 Score on a scale Standard Deviation 27.89	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 60	0.0 Score on a scale Standard Deviation 0.00	-8.3 Score on a scale Standard Deviation 31.91	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 63	0.0 Score on a scale Standard Deviation 0.00	-11.1 Score on a scale Standard Deviation 19.25	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 66	-16.7 Score on a scale Standard Deviation 23.57	-16.7 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 69	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	-33.3 Score on a scale Standard Deviation 47.14	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 21	8.9 Score on a scale Standard Deviation 19.36	6.7 Score on a scale Standard Deviation 21.07	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 3	-2.2 Score on a scale Standard Deviation 16.24	-3.2 Score on a scale Standard Deviation 24.48	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 6	0.4 Score on a scale Standard Deviation 19.73	-3.9 Score on a scale Standard Deviation 24.89	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 9	0.5 Score on a scale Standard Deviation 19.09	-3.8 Score on a scale Standard Deviation 22.37	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 12	1.1 Score on a scale Standard Deviation 23.16	-3.3 Score on a scale Standard Deviation 24.32	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 15	0.7 Score on a scale Standard Deviation 25.38	-0.7 Score on a scale Standard Deviation 24.05	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 18	0.7 Score on a scale Standard Deviation 21.59	-4.1 Score on a scale Standard Deviation 26.90	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 21	2.5 Score on a scale Standard Deviation 26.57	0.9 Score on a scale Standard Deviation 18.15	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 24	1.9 Score on a scale Standard Deviation 21.30	-1.0 Score on a scale Standard Deviation 17.38	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 27	2.9 Score on a scale Standard Deviation 19.88	6.2 Score on a scale Standard Deviation 27.79	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 30	3.7 Score on a scale Standard Deviation 19.43	6.7 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 33	-5.1 Score on a scale Standard Deviation 18.49	0.0 Score on a scale Standard Deviation 15.71	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 36	-9.1 Score on a scale Standard Deviation 15.57	0.0 Score on a scale Standard Deviation 21.82	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 39	0.0 Score on a scale Standard Deviation 22.22	9.5 Score on a scale Standard Deviation 30.46	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 42	0.0 Score on a scale Standard Deviation 15.71	0.0 Score on a scale Standard Deviation 17.82	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 45	0.0 Score on a scale Standard Deviation 19.25	8.3 Score on a scale Standard Deviation 15.08	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 48	0.0 Score on a scale Standard Deviation 21.08	11.1 Score on a scale Standard Deviation 16.67	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 51	0.0 Score on a scale Standard Deviation 21.08	10.0 Score on a scale Standard Deviation 22.50	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 54	0.0 Score on a scale Standard Deviation 21.08	9.5 Score on a scale Standard Deviation 31.71	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 57	0.0 Score on a scale Standard Deviation 0.00	20.0 Score on a scale Standard Deviation 18.26	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 60	-11.1 Score on a scale Standard Deviation 19.25	25.0 Score on a scale Standard Deviation 16.67	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 63	0.0 Score on a scale Standard Deviation 33.33	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 66	0.0 Score on a scale Standard Deviation 47.14	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 69	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 72	—	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 75	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Week 78	—	33.3 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain:Post treatment efficacy visit 1	0.0 Score on a scale Standard Deviation 0.00	-22.2 Score on a scale Standard Deviation 19.25	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Post treatment efficacy visit 2	11.1 Score on a scale Standard Deviation 19.25	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Post treatment efficacy visit 3	—	16.7 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: Post treatment efficacy visit 5	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: 7 days post disease progression	5.4 Score on a scale Standard Deviation 17.42	-5.7 Score on a scale Standard Deviation 21.95	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Chest pain: 28 days post disease progression	14.8 Score on a scale Standard Deviation 26.13	-2.1 Score on a scale Standard Deviation 25.73	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 3	0.0 Score on a scale Standard Deviation 21.54	-3.2 Score on a scale Standard Deviation 24.03	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 6	3.0 Score on a scale Standard Deviation 26.42	-4.7 Score on a scale Standard Deviation 27.77	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 9	2.6 Score on a scale Standard Deviation 32.44	0.5 Score on a scale Standard Deviation 25.69	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 12	4.8 Score on a scale Standard Deviation 33.79	0.0 Score on a scale Standard Deviation 26.75	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 15	2.0 Score on a scale Standard Deviation 27.82	-0.7 Score on a scale Standard Deviation 24.05	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 18	-1.3 Score on a scale Standard Deviation 26.63	0.0 Score on a scale Standard Deviation 31.18	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 21	-4.2 Score on a scale Standard Deviation 30.37	-4.4 Score on a scale Standard Deviation 28.13	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 24	-1.0 Score on a scale Standard Deviation 31.81	-3.9 Score on a scale Standard Deviation 24.29	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 54	16.7 Score on a scale Standard Deviation 18.26	-4.8 Score on a scale Standard Deviation 23.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 72	—	-33.3 Score on a scale Standard Deviation 47.14	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 75	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Week 78	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Post treatment efficacy visit 1	0.0 Score on a scale Standard Deviation 0.00	0.0 Score on a scale Standard Deviation 0.00	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Post treatment efficacy visit 2	-22.2 Score on a scale Standard Deviation 19.25	33.3 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Post treatment efficacy visit 3	—	-16.7 Score on a scale Standard Deviation 23.57	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: Post treatment efficacy visit 5	—	0.0 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: 7 days post disease progression	-1.1 Score on a scale Standard Deviation 25.07	3.4 Score on a scale Standard Deviation 31.30	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Coughing: 28 days post disease progression	-3.7 Score on a scale Standard Deviation 27.75	-4.2 Score on a scale Standard Deviation 31.91	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 3	4.8 Score on a scale Standard Deviation 17.84	2.9 Score on a scale Standard Deviation 18.47	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 6	4.4 Score on a scale Standard Deviation 16.83	5.0 Score on a scale Standard Deviation 19.59	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 9	4.8 Score on a scale Standard Deviation 19.44	5.2 Score on a scale Standard Deviation 20.17	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 12	7.4 Score on a scale Standard Deviation 19.25	6.9 Score on a scale Standard Deviation 20.57	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 15	6.5 Score on a scale Standard Deviation 16.66	10.9 Score on a scale Standard Deviation 21.69	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 18	10.2 Score on a scale Standard Deviation 19.98	4.3 Score on a scale Standard Deviation 22.43	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 24	7.9 Score on a scale Standard Deviation 23.89	9.2 Score on a scale Standard Deviation 20.19	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 27	10.1 Score on a scale Standard Deviation 21.43	8.6 Score on a scale Standard Deviation 20.52	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 30	8.0 Score on a scale Standard Deviation 14.66	8.0 Score on a scale Standard Deviation 21.40	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 33	13.7 Score on a scale Standard Deviation 17.66	7.0 Score on a scale Standard Deviation 22.89	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 36	12.1 Score on a scale Standard Deviation 22.47	7.4 Score on a scale Standard Deviation 21.28	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 39	14.4 Score on a scale Standard Deviation 16.60	10.3 Score on a scale Standard Deviation 25.21	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 42	20.0 Score on a scale Standard Deviation 27.62	3.0 Score on a scale Standard Deviation 23.18	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 45	20.6 Score on a scale Standard Deviation 26.00	13.0 Score on a scale Standard Deviation 20.56	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 48	20.4 Score on a scale Standard Deviation 30.97	14.8 Score on a scale Standard Deviation 13.61	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 51	22.2 Score on a scale Standard Deviation 29.81	7.8 Score on a scale Standard Deviation 15.76	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 54	22.2 Score on a scale Standard Deviation 26.29	12.7 Score on a scale Standard Deviation 13.50	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 57	19.4 Score on a scale Standard Deviation 31.91	11.1 Score on a scale Standard Deviation 11.11	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 60	25.9 Score on a scale Standard Deviation 44.91	-2.8 Score on a scale Standard Deviation 24.64	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 63	18.5 Score on a scale Standard Deviation 44.91	-3.7 Score on a scale Standard Deviation 12.83	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 66	-11.1 Score on a scale Standard Deviation 15.71	0.0 Score on a scale Standard Deviation 15.71	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 69	-22.2 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	-11.1 Score on a scale Standard Deviation 47.14	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 72	—	-11.1 Score on a scale Standard Deviation 47.14	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 75	—	22.2 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Week 78	—	22.2 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Post treatment efficacy visit 1	16.7 Score on a scale Standard Deviation 23.57	3.7 Score on a scale Standard Deviation 16.97	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Post treatment efficacy visit 2	-3.7 Score on a scale Standard Deviation 44.91	22.2 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Post treatment efficacy visit 3	—	16.7 Score on a scale Standard Deviation 7.86	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: Post treatment efficacy visit 5	—	-11.1 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: 7 days post disease progression	5.0 Score on a scale Standard Deviation 17.88	2.3 Score on a scale Standard Deviation 20.22	—
Randomized Part: Change From Baseline in Chest Pain, Cough and Dyspnea Scores as Per the EORTC-QLQ LC13 Questionnaire Dyspnea: 28 days post disease progression	3.7 Score on a scale Standard Deviation 16.61	10.4 Score on a scale Standard Deviation 19.23	—

SECONDARY outcome

Population: FAS in Randomized part: All participants to whom study treatment was assigned by randomization. Number analyzed represents participants with data available at the specified data points

The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). A positive change from baseline indicates improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits 1, 2, 3 and 5 were conducted every 6 weeks (for the first 12 months since start of treatment) and every 12 weeks (after 12 months since start of treatment) until disease progression

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 3	-0.017 Score on a scale Standard Deviation 0.1960	-0.007 Score on a scale Standard Deviation 0.1731	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 6	-0.016 Score on a scale Standard Deviation 0.1972	0.001 Score on a scale Standard Deviation 0.2283	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 9	-0.006 Score on a scale Standard Deviation 0.1759	0.011 Score on a scale Standard Deviation 0.1865	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 12	-0.028 Score on a scale Standard Deviation 0.1849	0.014 Score on a scale Standard Deviation 0.2315	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 15	-0.057 Score on a scale Standard Deviation 0.2229	-0.042 Score on a scale Standard Deviation 0.1827	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 18	-0.062 Score on a scale Standard Deviation 0.1835	0.009 Score on a scale Standard Deviation 0.2810	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 21	-0.097 Score on a scale Standard Deviation 0.2234	0.005 Score on a scale Standard Deviation 0.1952	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 24	-0.070 Score on a scale Standard Deviation 0.2075	0.027 Score on a scale Standard Deviation 0.1900	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 27	-0.043 Score on a scale Standard Deviation 0.1820	0.008 Score on a scale Standard Deviation 0.2272	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 30	-0.023 Score on a scale Standard Deviation 0.2378	-0.014 Score on a scale Standard Deviation 0.2068	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 33	-0.031 Score on a scale Standard Deviation 0.2148	0.029 Score on a scale Standard Deviation 0.2361	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 36	0.017 Score on a scale Standard Deviation 0.1942	0.050 Score on a scale Standard Deviation 0.2743	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 39	-0.007 Score on a scale Standard Deviation 0.1898	-0.012 Score on a scale Standard Deviation 0.2842	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 42	-0.010 Score on a scale Standard Deviation 0.2286	0.116 Score on a scale Standard Deviation 0.2180	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 45	0.017 Score on a scale Standard Deviation 0.1866	-0.036 Score on a scale Standard Deviation 0.1801	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 48	-0.087 Score on a scale Standard Deviation 0.3178	0.003 Score on a scale Standard Deviation 0.2424	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 51	-0.151 Score on a scale Standard Deviation 0.2663	0.071 Score on a scale Standard Deviation 0.2197	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 54	-0.102 Score on a scale Standard Deviation 0.3527	0.056 Score on a scale Standard Deviation 0.2011	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 57	0.476 Score on a scale Standard Deviation 0.2190	0.652 Score on a scale Standard Deviation 0.1308	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 60	-0.193 Score on a scale Standard Deviation 0.3653	0.149 Score on a scale Standard Deviation 0.1616	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 63	-0.140 Score on a scale Standard Deviation 0.3435	0.165 Score on a scale Standard Deviation 0.1717	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 66	0.034 Score on a scale Standard Deviation 0.0481	0.124 Score on a scale Standard Deviation 0.0085	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 69	0.000 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	0.340 Score on a scale Standard Deviation 0.1230	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 72	—	0.168 Score on a scale Standard Deviation 0.0530	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 75	—	0.130 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Week 78	—	0.130 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Post treatment efficacy visit 1	0.100 Score on a scale Standard Deviation 0.0955	-0.026 Score on a scale Standard Deviation 0.0368	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Post treatment efficacy visit 2	0.644 Score on a scale Standard Deviation 0.1749	0.704 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Post treatment efficacy visit 3	—	0.601 Score on a scale Standard Deviation 0.0990	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores Post treatment efficacy visit 5	—	1.000 Score on a scale Standard Deviation NA NA: The standard deviation was not estimable as there was only one participant.	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores 7 days post disease progression	0.639 Score on a scale Standard Deviation 0.2558	0.657 Score on a scale Standard Deviation 0.2654	—
Randomized Part: Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores 28 days post disease progression	0.692 Score on a scale Standard Deviation 0.1633	0.692 Score on a scale Standard Deviation 0.2149	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Population: Canakinumab pharmacokinetic analysis set (PAS) in safety run-in part: all subjects who received at least one dose of canakinumab in the safety run-in part and have at least one evaluable canakinumab pharmacokinetic (PK) concentration. Only participants with an evaluable PK sample collected at each timepoint were included in this analysis.

Venous whole blood samples were collected for pharmacokinetics characterization. Cmax of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=6 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Maximum Plasma Concentration (Cmax) of Canakinumab	13.4 microgram/milliliter (ug/mL) Geometric Coefficient of Variation 29.9	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Population: Canakinumab PAS in safety run-in part: all subjects who received at least one dose of canakinumab in the safety run-in part and have at least one evaluable canakinumab PK concentration. Only participants with an evaluable PK sample collected at each timepoint were included in this analysis

Venous whole blood samples were collected for pharmacokinetics characterization. Tmax of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=6 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Time of Maximum Plasma Concentration (Tmax) of Canakinumab	169 Hours (h) Interval 48.2 to 336.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 at pre-dose and end of infusion and 24, 48, 168 and 336 hours (h) post-infusion. Each cycle is 21 days

Venous whole blood samples were collected for pharmacokinetics characterization. AUClast of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=6 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Canakinumab	5470 hourmicrogram/mililiter (hrug/mL) Geometric Coefficient of Variation 30.5	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Population: Docetaxel PAS in safety run-in part: all subjects who received at least one dose of canakinumab in the safety run-in part and have at least one evaluable docetaxel PK concentration. Number analyzed represents participants evaluable at specified time points

Venous whole blood samples were collected for pharmacokinetics characterization. Cmax of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Cmax of Docetaxel Cycle 1 Day 1	476 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 182.5	—	—
Safety run-in Part: Cmax of Docetaxel Cycle 2 Day 1	1630 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 117.2	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Venous whole blood samples were collected for pharmacokinetics characterization. Tmax of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics. Actual recorded sampling times were considered for the calculations.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: Tmax of Docetaxel Cycle 1 Day 1	1.08 Hour (hr) Interval 0.917 to 6.12	—	—
Safety run-in Part: Tmax of Docetaxel Cycle 2 Day 1	1.00 Hour (hr) Interval 0.917 to 1.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 at pre-infusion, end of infusion, and 2, 4, 6 and 8 hours post-dose. Each cycle is 21 days

Venous whole blood samples were collected for pharmacokinetics characterization. AUClast of docetaxel was calculated from docetaxel plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Safety run-in Part: AUClast of Docetaxel Cycle 1 Day 1	884 Hour nanogram/miliLiter (hrng/mL) Geometric Coefficient of Variation 70.8	—	—
Safety run-in Part: AUClast of Docetaxel Cycle 2 Day 1	2120 Hour nanogram/miliLiter (hrng/mL) Geometric Coefficient of Variation 86.5	—	—

SECONDARY outcome

Timeframe: Pre-dose on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 and Cycle 18 Day 1. Each cycle is 21 days.

Population: Canakinumab PAS in randomized part: all subjects who received at least one dose of canakinumab in the randomized part and have at least one evaluable canakinumab pharmacokinetic (PK) concentration. Number analyzed represents participants evaluable at specified time points.

Venous whole blood samples were collected for pharmacokinetics characterization. CTrough of canakinumab was calculated from canakinumab plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=112 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab Cycle 1 Day 1	0 microgram/miliLiter (ug/mL) Geometric Coefficient of Variation 0	—	—
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab Cycle 4 Day 1	20.5 microgram/miliLiter (ug/mL) Geometric Coefficient of Variation 36.6	—	—
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab Cycle 6 Day 1	23.7 microgram/miliLiter (ug/mL) Geometric Coefficient of Variation 32.3	—	—
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab Cycle 12 Day 1	25.6 microgram/miliLiter (ug/mL) Geometric Coefficient of Variation 56.7	—	—
Randomized Part: Pre-dose Plasma Trough Concentration (CTrough) of Canakinumab Cycle 18 Day 1	28.3 microgram/miliLiter (ug/mL) Geometric Coefficient of Variation 118.0	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Population: Docetaxel PAS in randomized part: all subjects who received at least one dose of canakinumab in the randomized part and have at least one evaluable docetaxel PK concentration. Number analyzed represents participants evaluable at specified time points

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=26 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=23 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Cmax of Docetaxel Cycle 1 Day 1	1570 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 116.3	1190 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 265.3	—
Randomized Part: Cmax of Docetaxel Cycle 4 Day 1	1530 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 118.7	940 nanogram/miliLiter (ng/mL) Geometric Coefficient of Variation 215.8	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=26 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=23 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Tmax of Docetaxel Cycle 1 Day 1	1.09 Hour Interval 0.517 to 5.83	1.10 Hour Interval 0.933 to 6.08	—
Randomized Part: Tmax of Docetaxel Cycle 4 Day 1	1.15 Hour Interval 0.0833 to 3.83	1.08 Hour Interval 1.0 to 1.42	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1 and Cycle 4 Day 1 at pre-infusion, end of infusion, and 2, 4 and 6 hours post-dose. Each cycle is 21 days

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=22 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=19 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: AUClast of Docetaxel Cycle 1 Day 1	2530 hournanogram/miliLiter (hng/mL) Geometric Coefficient of Variation 79.3	1790 hournanogram/miliLiter (hng/mL) Geometric Coefficient of Variation 157.4	—
Randomized Part: AUClast of Docetaxel Cycle 4 Day 1	2210 hournanogram/miliLiter (hng/mL) Geometric Coefficient of Variation 66.4	1530 hournanogram/miliLiter (hng/mL) Geometric Coefficient of Variation 130.9	—

SECONDARY outcome

Timeframe: Baseline

Population: All participants randomized to canakinumab+docetaxel arm

ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Canakinumab Antidrug Antibodies (ADA) at Baseline	1 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose at Cycle 1 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1 , end of treatment, and 130 days after end of treatment through final analysis data cutoff date of 08-Jan-2021 (assessed up to 18 months). Each cycle is 21 days

Population: All participants randomized to canakinumab+docetaxel arm

ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=120 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
Randomized Part: Canakinumab ADA Incidence On-treatment	0 Participants	—	—

POST_HOC outcome

Timeframe: Pre-treatment: up to 28 days before Day 1;On-treatment: up to approximately 10 months (safety run-in) or 25 months (randomized); post-treatment survival follow-up deaths: Up to approximately 16 months (safety run in) or 25 months (randomized)

Population: Safety run-in part: FAS including all subjects to whom study treatment was assigned. Randomized part: FAS including all participants to whom study treatment was assigned by randomization

Pre-treatment deaths were collected from screening to the first day of treatment, for a maximum duration of 28 days. On-treatment deaths due to any cause were collected from first dose of study treatment to 130 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from day 131 after last dose of study treatment to end of study. All deaths refer to the sum of pre-treatment, on-treatment and post-treatment deaths.

Outcome measures

Outcome measures
Measure	Safety run-in Part: Canakinumab+Docetaxel n=8 Participants Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1).	Randomized Part: Placebo + Docetaxel n=120 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle	Randomized Part: Placebo + Docetaxel n=117 Participants Participants were randomized to receive placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 on Day 1 of each 21-Day cycle
All Collected Deaths Pre-treatment deaths	0 Participants	0 Participants	1 Participants
All Collected Deaths On-treatment deaths	6 Participants	45 Participants	37 Participants
All Collected Deaths Post-treatment survival follow-up deaths	2 Participants	40 Participants	38 Participants
All Collected Deaths All deaths	8 Participants	85 Participants	76 Participants

Adverse Events

All Participants (Pre-treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Safety run-in Part: Canakinumab+Docetaxel (On-treatment)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 6 deaths

Safety run-in Part: Canakinumab+Docetaxel (Post-treatment Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Randomized Part: Canakinumab + Docetaxel (On-treatment)

Serious events: 55 serious events

Other events: 111 other events

Deaths: 45 deaths

Randomized Part: Canakinumab + Docetaxel (Post-treatment Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 40 deaths

Randomized Part: Placebo + Docetaxel (On-treatment)

Serious events: 50 serious events

Other events: 109 other events

Deaths: 37 deaths

Randomized Part: Placebo + Docetaxel (Post-treatment Follow-up)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 38 deaths

Serious adverse events

Serious adverse events
Measure	All Participants (Pre-treatment) Deaths were collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment )	Safety run-in Part: Canakinumab+Docetaxel (On-treatment) n=8 participants at risk AEs during on-treatment period (up to 130 days post-treatment)	Safety run-in Part: Canakinumab+Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period	Randomized Part: Canakinumab + Docetaxel (On-treatment) n=120 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Randomized Part: Canakinumab + Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post-treatment). No AEs were collected during this period	Randomized Part: Placebo + Docetaxel (On-treatment) n=114 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Randomized Part: Placebo + Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Febrile neutropenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Leukopenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Neutropenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.4% 5/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Thrombocytopenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Atrial fibrillation	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Cardiac tamponade	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Cardio-respiratory arrest	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Pericardial effusion	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Endocrine disorders Hypopituitarism	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Abdominal pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Abdominal pain upper	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Colitis ulcerative	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Diarrhoea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Dysphagia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Gastrointestinal haemorrhage	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Ileus	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Lower gastrointestinal haemorrhage	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Nausea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Small intestine ulcer	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Stomatitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Vomiting	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Asthenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Chest pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Disease progression	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Fatigue	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Generalised oedema	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Malaise	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Mucosal inflammation	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Oedema peripheral	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Pyrexia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Abdominal sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Bacteraemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Bacterial infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Bronchitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations COVID-19	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations COVID-19 pneumonia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Clostridium difficile colitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Device related infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Diverticulitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Erysipelas	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Escherichia sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Escherichia urinary tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Febrile infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Gastroenteritis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Gastroenteritis viral	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Infectious pleural effusion	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Influenza	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Lower respiratory tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Neutropenic sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Pneumonia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	10.8% 13/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Pneumonia pneumococcal	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Pneumonia pseudomonal	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Post procedural sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Pulmonary sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Respiratory tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.5% 3/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.5% 4/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Sepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Septic shock	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.5% 3/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Spinal cord infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Upper respiratory tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Urinary tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.5% 4/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Urosepsis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Vulvovaginitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Injury, poisoning and procedural complications Femur fracture	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Injury, poisoning and procedural complications Hip fracture	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Injury, poisoning and procedural complications Lumbar vertebral fracture	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Injury, poisoning and procedural complications Procedural pneumothorax	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Aspartate aminotransferase increased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Gamma-glutamyltransferase increased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Neutrophil count decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations White blood cell count decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Decreased appetite	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Dehydration	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Diabetic ketoacidosis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Hypercalcaemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Back pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Bone pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Fistula	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Cerebrovascular accident	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Dizziness	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Ischaemic stroke	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Monoplegia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Syncope	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Renal and urinary disorders Acute kidney injury	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Reproductive system and breast disorders Balanoposthitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Asthma	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.4% 5/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.5% 3/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Hypoxia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.7% 2/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Pneumonitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Pneumothorax	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Respiratory failure	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.5% 3/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Aneurysm	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Haematoma	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Hypotension	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Superior vena cava syndrome	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Thrombosis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment

Other adverse events

Other adverse events
Measure	All Participants (Pre-treatment) Deaths were collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment )	Safety run-in Part: Canakinumab+Docetaxel (On-treatment) n=8 participants at risk AEs during on-treatment period (up to 130 days post-treatment)	Safety run-in Part: Canakinumab+Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period	Randomized Part: Canakinumab + Docetaxel (On-treatment) n=120 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Randomized Part: Canakinumab + Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post-treatment). No AEs were collected during this period	Randomized Part: Placebo + Docetaxel (On-treatment) n=114 participants at risk AEs during on-treatment period (up to 30 days post-treatment)	Randomized Part: Placebo + Docetaxel (Post-treatment Follow-up) Deaths collected in the post- treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	26.7% 32/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	28.9% 33/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Leukopenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	13.2% 15/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Blood and lymphatic system disorders Neutropenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	18.3% 22/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	21.9% 25/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Atrial fibrillation	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Cardiac disorders Tachycardia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Endocrine disorders Cushingoid	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Abdominal pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.5% 4/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Constipation	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	18.3% 22/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	21.1% 24/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Diarrhoea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	37.5% 3/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	34.2% 41/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	27.2% 31/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Dyspepsia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Nausea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	23.3% 28/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.4% 29/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Odynophagia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Stomatitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.5% 9/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Gastrointestinal disorders Vomiting	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 15/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.3% 14/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Asthenia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	23.3% 28/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	32.5% 37/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Chest pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.8% 10/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Fatigue	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	27.5% 33/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	16.7% 19/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Influenza like illness	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Malaise	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Mucosal inflammation	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	10.5% 12/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Oedema	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Oedema peripheral	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	37.5% 3/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	18.3% 22/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	21.9% 25/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
General disorders Pyrexia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	11.7% 14/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	15.8% 18/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Bronchitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Folliculitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Nasopharyngitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Pneumonia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.5% 4/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Respiratory tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Upper respiratory tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Infections and infestations Urinary tract infection	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.7% 8/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Alanine aminotransferase increased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Aspartate aminotransferase increased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Gamma-glutamyltransferase increased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Haemoglobin decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Neutrophil count decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	14.2% 17/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	9.6% 11/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations SARS-CoV-2 test negative	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.3% 10/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	11.4% 13/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations Weight decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.5% 9/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Investigations White blood cell count decreased	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	10.0% 12/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Decreased appetite	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	26.7% 32/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	27.2% 31/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Hyperglycaemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.4% 5/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Hypoalbuminaemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.7% 8/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Hyponatraemia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Metabolism and nutrition disorders Steroid diabetes	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	9.2% 11/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.8% 10/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Back pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.7% 8/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Muscular weakness	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Musculoskeletal pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.5% 9/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.9% 9/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Dysgeusia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.7% 8/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Headache	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.7% 8/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Neuropathy peripheral	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.5% 9/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	13.2% 15/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Paraesthesia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	10.0% 12/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Nervous system disorders Taste disorder	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.83% 1/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Psychiatric disorders Anxiety	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	1.8% 2/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Psychiatric disorders Insomnia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	13.3% 16/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	16.7% 19/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.0% 2/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	22.5% 27/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	22.8% 26/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.5% 3/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.4% 5/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Epistaxis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.2% 5/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Haemoptysis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.3% 10/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.8% 10/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.3% 6/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Respiratory, thoracic and mediastinal disorders Productive cough	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	2.6% 3/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Alopecia	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	25.8% 31/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	38.6% 44/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Dry skin	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	3.3% 4/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	6.1% 7/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Nail disorder	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.8% 7/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.0% 8/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Night sweats	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Pruritus	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.3% 10/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	7.9% 9/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Psoriasis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.88% 1/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Skin and subcutaneous tissue disorders Rash	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	10.0% 12/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	8.8% 10/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Hypotension	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	5.0% 6/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	4.4% 5/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment
Vascular disorders Phlebitis	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	12.5% 1/8 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/120 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	0.00% 0/114 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment	— 0/0 • Treatment-emergent Adverse events (AEs) were collected from first administration of study treatment to 130 days after date of last administration, up to approximately 10 months (safety run-in) or 25 months (randomized). Deaths were collected from day of subject's informed consent until end of study, up to approximately 16 months (safety run in) or 25 months (randomized) Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set. This set includes all subjects who were assigned study treatment and received at least one dose, including incomplete infusions. All-Cause Mortality analysis encompasses the Full Analysis Set, including all subjects who were assigned study treatment

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER