Trial Outcomes & Findings for A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (NCT NCT04710576)

NCT ID: NCT04710576

Last Updated: 2025-09-03

Results Overview

The ORR was defined as the percentage of participants with objective response (complete response \[CR\] or partial response \[PR\]). CR was defined as resolution of all manifestations in each organ or site, and PR was defined as improvement in at least 1 organ or site without progression in any other organ or site.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 241 participants
• Primary outcome timeframe: First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks)
• Results posted on: 2025-09-03

Participant Flow

The primary analysis results are reported. The final results will be posted after completion of the study.

Participant milestones

Measure	Axatilimab 0.3 mg/kg Q2W Participants received axatilimab 0.3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W Participants received axatilimab 3 mg/kg IV every 4 weeks (Q4W) (Day 1 of each 4-week cycle) for up to 2 years.
Overall Study STARTED	80	81	80
Overall Study Received at Least 1 Dose of Study Drug	79	81	79
Overall Study COMPLETED	0	1	1
Overall Study NOT COMPLETED	80	80	79

Reasons for withdrawal

Measure	Axatilimab 0.3 mg/kg Q2W Participants received axatilimab 0.3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W Participants received axatilimab 3 mg/kg IV every 4 weeks (Q4W) (Day 1 of each 4-week cycle) for up to 2 years.
Overall Study Participants still in the study	73	70	60
Overall Study Death	2	7	12
Overall Study Withdrawal by Subject	4	3	7
Overall Study Sponsor decision	1	0	0

Baseline Characteristics

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Baseline characteristics by cohort

Measure	Axatilimab 0.3 mg/kg Q2W n=80 Participants Participants received axatilimab 0.3 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W n=81 Participants Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W n=80 Participants Participants received axatilimab 3 mg/kg IV Q4W (Day 1 of each 4-week cycle) for up to 2 years.	Total n=241 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 16.88 • n=5 Participants	54.0 years STANDARD_DEVIATION 12.65 • n=7 Participants	50.8 years STANDARD_DEVIATION 16.02 • n=5 Participants	51.4 years STANDARD_DEVIATION 15.34 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	90 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	51 Participants n=7 Participants	53 Participants n=5 Participants	151 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	69 Participants n=7 Participants	73 Participants n=5 Participants	215 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	70 Participants n=7 Participants	62 Participants n=5 Participants	200 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants

PRIMARY outcome

Timeframe: First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks)

Population: The ITT analysis set for each dose level included all participants randomized to the dose level.

The ORR was defined as the percentage of participants with objective response (complete response [CR] or partial response [PR]). CR was defined as resolution of all manifestations in each organ or site, and PR was defined as improvement in at least 1 organ or site without progression in any other organ or site.

Outcome measures

Measure	Axatilimab 0.3 mg/kg Q2W n=80 Participants Participants received axatilimab 0.3 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W n=81 Participants Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W n=80 Participants Participants received axatilimab 3 mg/kg IV Q4W (Day 1 of each 4-week cycle) for up to 2 years.
Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD)	73.8 percentage of participants Interval 62.7 to 83.0	66.7 percentage of participants Interval 55.3 to 76.8	50.0 percentage of participants Interval 38.6 to 61.4

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Duration of response is defined as the time from initial partial response or complete response until documented progression of cGVHD, start of new therapy, or death for any reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Sustained response rate is defined as the number of participants with objective response lasting for at least 20 weeks (140 days) from the time of initial response. Responses will be assessed based on the 2014 NIH Consensus Development Project on Clinical Trials in cGVHD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Organ-specific response is defined as the number of participants with objective response for the nine individual organs based on 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (skin, eyes, mouth, esophagus, upper gastrointestinal [GI], lower GI, liver, lungs and joints and fascia).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to 2 years

Outcome measures

Outcome data not reported

Adverse Events

Axatilimab 0.3 mg/kg Q2W

Serious events: 30 serious events

Other events: 74 other events

Deaths: 2 deaths

Axatilimab 1 mg/kg Q2W

Serious events: 33 serious events

Other events: 78 other events

Deaths: 7 deaths

Axatilimab 3 mg/kg Q4W

Serious events: 38 serious events

Other events: 78 other events

Deaths: 12 deaths

Serious adverse events

Measure	Axatilimab 0.3 mg/kg Q2W n=79 participants at risk Participants received axatilimab 0.3 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W n=81 participants at risk Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W n=79 participants at risk Participants received axatilimab 3 mg/kg IV Q4W (Day 1 of each 4-week cycle) for up to 2 years.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Aortic valve incompetence	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Atrial fibrillation	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Cardiac failure	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Cardiac failure acute	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Cardiac failure congestive	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Myocardial infarction	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Myocarditis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Eye disorders Eye disorder	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Ascites	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Colitis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Diarrhoea	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Enterocolitis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Nausea	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Vomiting	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Asthenia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Face oedema	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Generalised oedema	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Non-cardiac chest pain	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Pain	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Pyrexia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Sudden cardiac death	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Hepatobiliary disorders Cholecystitis acute	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Hepatobiliary disorders Hepatic cytolysis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Immune system disorders Acute graft versus host disease	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Immune system disorders Anaphylactic reaction	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Immune system disorders Chronic graft versus host disease	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Immune system disorders Overlap syndrome	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Bacteraemia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Bronchiolitis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Bronchitis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations COVID-19	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations COVID-19 pneumonia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Campylobacter infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Cellulitis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Clostridium difficile infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Coronavirus infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Cryptosporidiosis infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Device related infection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Enterococcal infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Enterovirus infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Erysipelas	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Gastroenteritis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Gastroenteritis astroviral	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Haemophilus infection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Herpes simplex	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Herpes zoster	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Influenza	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Liver abscess	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Mastitis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Meningitis enteroviral	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Metapneumovirus infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Mycobacterial infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Neutropenic sepsis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Oral infection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Parainfluenzae viral bronchitis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Parainfluenzae virus infection	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Pneumonia	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	9.9% 8/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Pseudomonal sepsis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Pseudomonal skin infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Respiratory syncytial virus infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Respiratory tract infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Rhinovirus infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Sepsis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Septic shock	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Skin infection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Staphylococcal bacteraemia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Streptococcal infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Streptococcal sepsis	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Superinfection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Viral infection	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Viral upper respiratory tract infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Traumatic fracture	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Vascular access complication	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Lipase increased	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Platelet count decreased	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Sapovirus test positive	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Streptococcus test positive	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Decreased appetite	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hypercalcaemia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Malnutrition	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia recurrent	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Embolic stroke	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Presyncope	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Unresponsive to stimuli	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Psychiatric disorders Confusional state	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Renal and urinary disorders Haematuria	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Renal and urinary disorders Nephrolithiasis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Renal and urinary disorders Proteinuria	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Embolism	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Hypertension	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Hypotension	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Peripheral artery thrombosis	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Shock haemorrhagic	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Organising Pneumonia	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.

Other adverse events

Measure	Axatilimab 0.3 mg/kg Q2W n=79 participants at risk Participants received axatilimab 0.3 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 1 mg/kg Q2W n=81 participants at risk Participants received axatilimab 1 mg/kg IV Q2W (Days 1 and 15 of each 4-week cycle) for up to 2 years.	Axatilimab 3 mg/kg Q4W n=79 participants at risk Participants received axatilimab 3 mg/kg IV Q4W (Day 1 of each 4-week cycle) for up to 2 years.
Blood and lymphatic system disorders Anaemia	12.7% 10/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	12.7% 10/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Cardiac disorders Tachycardia	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Eye disorders Dry eye	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Eye disorders Eyelid oedema	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Eye disorders Periorbital oedema	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	23.5% 19/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	29.1% 23/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Abdominal pain	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Abdominal pain upper	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Constipation	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Diarrhoea	16.5% 13/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	22.2% 18/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Dyspepsia	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Dysphagia	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Nausea	16.5% 13/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	17.3% 14/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Gastrointestinal disorders Vomiting	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Chills	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Face oedema	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Fatigue	22.8% 18/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	19.8% 16/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	26.6% 21/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Influenza like illness	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Non-cardiac chest pain	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Oedema peripheral	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	14.8% 12/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
General disorders Pyrexia	11.4% 9/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	11.1% 9/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Bronchitis	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations COVID-19	15.2% 12/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	17.3% 14/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Influenza	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Nasopharyngitis	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Pneumonia	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Respiratory syncytial virus infection	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Respiratory tract infection	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Rhinovirus infection	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Sinusitis	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Upper respiratory tract infection	16.5% 13/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	13.6% 11/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Infections and infestations Viral upper respiratory tract infection	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Fall	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Injury, poisoning and procedural complications Infusion related reaction	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Alanine aminotransferase increased	12.7% 10/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	22.2% 18/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	39.2% 31/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Amylase increased	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	12.3% 10/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	43.0% 34/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Aspartate aminotransferase increased	13.9% 11/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	38.3% 31/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	54.4% 43/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Blood alkaline phosphatase increased	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	21.5% 17/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Blood creatine phosphokinase increased	11.4% 9/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	32.1% 26/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	62.0% 49/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Blood creatinine increased	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Blood lactate dehydrogenase increased	13.9% 11/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	27.2% 22/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	40.5% 32/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Gamma-glutamyltransferase increased	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	19.8% 16/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	26.6% 21/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Lipase increased	11.4% 9/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	25.9% 21/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	49.4% 39/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Platelet count decreased	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations SARS-CoV-2 test positive	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Investigations Weight decreased	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.6% 7/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Decreased appetite	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hyperglycaemia	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	9.9% 8/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hyperkalaemia	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hyperuricaemia	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.6% 7/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hypocalcaemia	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hypokalaemia	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hypomagnesaemia	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hyponatraemia	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Metabolism and nutrition disorders Hypophosphataemia	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	12.3% 10/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	15.2% 12/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 11/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	19.8% 16/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Back pain	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.6% 6/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	7.4% 6/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Myalgia	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	9.9% 8/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Dizziness	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	4.9% 4/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Nervous system disorders Headache	19.0% 15/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	17.3% 14/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	20.3% 16/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Renal and urinary disorders Dysuria	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.3% 1/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Cough	11.4% 9/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	12.3% 10/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.1% 8/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	9.9% 8/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.9% 7/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.7% 3/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	2.5% 2/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Skin and subcutaneous tissue disorders Alopecia	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	1.2% 1/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	0.00% 0/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Skin and subcutaneous tissue disorders Pruritus	5.1% 4/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	8.6% 7/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	15.2% 12/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Skin and subcutaneous tissue disorders Rash	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	6.2% 5/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	3.8% 3/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.
Vascular disorders Hypertension	6.3% 5/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	12.3% 10/81 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.	11.4% 9/79 • From first dose of study drug up to 2 years As pre-specified, All-cause mortality data were collected and reported for all enrolled participants; and Serious and Non-serious adverse events data were collected and reported for all participants who received at least 1 dose of study drug during the study.

Additional Information

Chief Medical Officer

Syndax Pharmaceuticals

Phone: 781-419-1400

Email: clinicaltrials@syndax.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of the results of the multi-center Study shall not be made before the first multi-site publication by Sponsor or Publications Committee. No Public Presentation by Institution or Investigator will be made until Study Documentation/Results from all sites are received and analyzed by Sponsor. Separate publication by Investigator will be delayed for a period of 18 months until the initial publication by Committee or Sponsor, or a determination is made not to make such publication.
• Publication restrictions are in place

Restriction type: OTHER