Trial Outcomes & Findings for A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL (NCT NCT03336333)

NCT ID: NCT03336333

Last Updated: 2025-03-07

Results Overview

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 590 participants
• Primary outcome timeframe: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)
• Results posted on: 2025-03-07

Participant Flow

Available data are presented as of the primary analysis data cut-off date of 07MAY2021; as of the data cut-off date, all cohorts were ongoing.

Participant milestones

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) Bendamustine + rituximab in participants with chronic lymphocytic leukemia (CLL) without deletion 17p \[del(17p)\]; bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Cohort 2: Zanubrutinib With Del(17p) Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
Overall Study STARTED	238	241	111
Overall Study Treated	227	240	111
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	238	241	111

Reasons for withdrawal

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) Bendamustine + rituximab in participants with chronic lymphocytic leukemia (CLL) without deletion 17p \[del(17p)\]; bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Cohort 2: Zanubrutinib With Del(17p) Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
Overall Study Remained on study at time of data cut-off	202	219	102
Overall Study Death	14	16	8
Overall Study Withdrawal by Subject	16	5	1
Overall Study Physician Decision	5	1	0
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Baseline characteristics by cohort

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) n=238 Participants Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) n=241 Participants Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Cohort 2: Zanubrutinib With Del(17p) n=111 Participants Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Total n=590 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	45 Participants n=7 Participants	16 Participants n=5 Participants	107 Participants n=4 Participants
Age, Categorical >=65 years	192 Participants n=5 Participants	196 Participants n=7 Participants	95 Participants n=5 Participants	483 Participants n=4 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	87 Participants n=7 Participants	32 Participants n=5 Participants	213 Participants n=4 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	154 Participants n=7 Participants	79 Participants n=5 Participants	377 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=5 Participants	218 Participants n=7 Participants	99 Participants n=5 Participants	528 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	206 Participants n=5 Participants	221 Participants n=7 Participants	105 Participants n=5 Participants	532 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	22 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	38 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021)

Population: ITT analysis set included all enrolled participants who were assigned to a treatment group

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).

Outcome measures

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) n=238 Participants Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) n=241 Participants Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day until unacceptable toxicity or disease progression
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)	33.7 Months Interval 28.1 to Not estimable due to low number of PFS events	NA Months Not estimable due to low number of PFS events

SECONDARY outcome

Timeframe: Up to 5 years

ORR in Cohort 1 is defined as the percentage of participants who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by the ICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Duration of response in Cohort 1 determined using the iwCLL criteria with modification for treatment related lymphocytosis (in participants with CLL) and the Lugano Classification for non-Hodgkin lymphoma (NHL; in participants with SLL), is defined as the time from the date that criteria for response (ie, partial response with lymphocytosis [PR-L] or better) are first met to the date that disease progression is objectively documented or death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per iwCLL guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose up to 12 hours postdose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose up to 12 hours postdose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose up to 12 hours postdose

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose up to 12 hours postdose

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: Bendamustine + Rituximab Without Del(17p)

Serious events: 113 serious events

Other events: 214 other events

Deaths: 14 deaths

Cohort 1: Zanubrutinib Without Del(17p)

Serious events: 88 serious events

Other events: 208 other events

Deaths: 16 deaths

Cohort 2: Zanubrutinib With Del(17p)

Serious events: 45 serious events

Other events: 104 other events

Deaths: 8 deaths

Serious adverse events

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) n=227 participants at risk Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) n=240 participants at risk Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Cohort 2: Zanubrutinib With Del(17p) n=111 participants at risk Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
Infections and infestations Appendicitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	2.2% 5/227 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	4.8% 11/227 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Immune thrombocytopenia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	1.8% 4/227 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Pancytopenia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Acute coronary syndrome	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Angina unstable	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Cardiovascular insufficiency	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Pulseless electrical activity	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Stress cardiomyopathy	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	2.2% 5/227 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal food impaction	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.44% 1/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Fatigue	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Hyperpyrexia	0.44% 1/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Implant site erosion	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Malaise	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Pyrexia	7.5% 17/227 • Number of events 19 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Systemic inflammatory response syndrome	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Biliary colic	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Gallbladder rupture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Hepatobiliary disorders Regenerative siderotic hepatic nodule	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Immune system disorders Drug hypersensitivity	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Abdominal sepsis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Abscess of salivary gland	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Cholecystitis infective	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Chronic sinusitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Disseminated varicella zoster virus infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Diverticulitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Endocarditis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Groin abscess	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations H3N2 influenza	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Hepatitis B reactivation	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Infected skin ulcer	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Infection	1.8% 4/227 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Influenza	0.44% 1/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Intervertebral discitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Neuroborreliosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Neutropenic sepsis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Otitis externa	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Otitis media acute	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Parainfluenzae virus infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pneumonia	3.1% 7/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pneumonia chlamydial	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pneumonia pneumococcal	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pneumonia viral	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Postoperative wound infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pseudomonal bacteraemia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pseudomonal sepsis	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection fungal	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Sepsis	2.6% 6/227 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Sialoadenitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Soft tissue infection	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Systemic candida	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Tick-borne fever	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	2.2% 5/227 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Urosepsis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Viral infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Viral pericarditis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Wound infection	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Chest injury	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	3.1% 7/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pelvic fracture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scrotal haematoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Stomal hernia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Blood pressure increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Adult failure to thrive	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Tumour lysis syndrome	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.44% 1/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) External ear neoplasm malignant	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma recurrent	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin squamous cell carcinoma metastatic	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma urethra	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Facial paralysis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Hydrocephalus	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Hypertensive encephalopathy	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Radial nerve palsy	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Bladder stenosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Calculus bladder	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Renal colic	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Ureteral polyp	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Urethral stenosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Reproductive system and breast disorders Perineal pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	1.3% 3/227 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Aortic dissection	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Aortic intramural haematoma	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Arteriosclerosis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.44% 1/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/240 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.

Other adverse events

Measure	Cohort 1: Bendamustine + Rituximab Without Del(17p) n=227 participants at risk Bendamustine + Rituximab in participants with CLL without del(17p); bendamustine 90 milligrams (mg)/m\^2/day administered intravenously (IV) on the first 2 days of each cycle for 6 cycles; rituximab 375 mg/m\^2 for Cycle 1 and 500 mg/m\^2 for Cycles 2 to 6 (each cycle is 28 days)	Cohort 1: Zanubrutinib Without Del(17p) n=240 participants at risk Zanubrutinib in participants with CLL without del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression	Cohort 2: Zanubrutinib With Del(17p) n=111 participants at risk Zanubrutinib in participants with CLL with del(17p); 160 mg administered twice a day orally until unacceptable toxicity or disease progression
Blood and lymphatic system disorders Anaemia	18.1% 41/227 • Number of events 65 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.6% 11/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.5% 5/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	3.1% 7/227 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	44.5% 101/227 • Number of events 233 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	12.5% 30/240 • Number of events 62 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	11.7% 13/111 • Number of events 28 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	13.2% 30/227 • Number of events 62 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Cardiac disorders Palpitations	1.3% 3/227 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.2% 10/240 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.88% 2/227 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	5.3% 12/227 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.6% 11/240 • Number of events 16 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	8.1% 9/111 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	18.9% 43/227 • Number of events 49 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	10.0% 24/240 • Number of events 26 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	15.3% 17/111 • Number of events 18 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	11.5% 26/227 • Number of events 37 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	13.8% 33/240 • Number of events 42 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	18.0% 20/111 • Number of events 24 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	4.0% 9/227 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	3.5% 8/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.2% 10/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	3.1% 7/227 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	32.6% 74/227 • Number of events 107 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	10.0% 24/240 • Number of events 30 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	16.2% 18/111 • Number of events 26 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	3.5% 8/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.1% 5/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	13.7% 31/227 • Number of events 40 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.1% 17/240 • Number of events 23 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.2% 8/111 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Asthenia	7.9% 18/227 • Number of events 25 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.1% 5/240 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Chest pain	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Chills	8.4% 19/227 • Number of events 21 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.5% 5/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Fatigue	15.9% 36/227 • Number of events 52 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	11.7% 28/240 • Number of events 37 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 14 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Oedema peripheral	7.0% 16/227 • Number of events 17 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.5% 18/240 • Number of events 25 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.2% 8/111 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Peripheral swelling	2.6% 6/227 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
General disorders Pyrexia	20.3% 46/227 • Number of events 69 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.2% 15/240 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Immune system disorders Drug hypersensitivity	3.5% 8/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Bronchitis	6.6% 15/227 • Number of events 17 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.5% 6/240 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations COVID-19	3.1% 7/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.7% 16/240 • Number of events 16 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.0% 12/240 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Conjunctivitis	2.6% 6/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	4.0% 9/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.1% 5/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	1.8% 4/227 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.3% 12/227 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.7% 16/240 • Number of events 16 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.9% 11/111 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Oral herpes	3.1% 7/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Pneumonia	5.7% 13/227 • Number of events 14 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.2% 8/111 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	3.5% 8/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 15 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.5% 5/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Sinusitis	4.4% 10/227 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.0% 12/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	11.9% 27/227 • Number of events 32 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	17.1% 41/240 • Number of events 53 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	20.7% 23/111 • Number of events 29 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	7.0% 16/227 • Number of events 28 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.7% 16/240 • Number of events 29 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	8.1% 9/111 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	3.5% 8/227 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	19.2% 46/240 • Number of events 58 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	19.8% 22/111 • Number of events 31 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	3.1% 7/227 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	8.1% 9/111 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	17.2% 39/227 • Number of events 44 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin laceration	1.8% 4/227 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	4.4% 10/227 • Number of events 18 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	4.0% 9/227 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.00% 0/111 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	12.3% 28/227 • Number of events 69 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.5% 6/240 • Number of events 14 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.3% 7/111 • Number of events 17 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Platelet count decreased	4.8% 11/227 • Number of events 20 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Investigations Weight decreased	3.1% 7/227 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.83% 2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	7.9% 18/227 • Number of events 18 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	3.5% 8/227 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	1.8% 4/227 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	4.0% 9/227 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.5% 6/240 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	5.3% 12/227 • Number of events 26 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.7% 4/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	8.4% 19/227 • Number of events 24 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	13.3% 32/240 • Number of events 40 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	19.8% 22/111 • Number of events 25 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	6.6% 15/227 • Number of events 20 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	8.8% 21/240 • Number of events 26 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	14.4% 16/111 • Number of events 19 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	4.0% 9/227 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.90% 1/111 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	1.8% 4/227 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.3% 7/111 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	1.3% 3/227 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.1% 5/240 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.3% 7/111 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 12/227 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.2% 15/240 • Number of events 23 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.3% 3/227 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	10.8% 12/111 • Number of events 17 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Dizziness	4.4% 10/227 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.9% 19/240 • Number of events 21 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.2% 8/111 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Headache	7.5% 17/227 • Number of events 19 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	10.8% 26/240 • Number of events 31 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.9% 11/111 • Number of events 14 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	1.8% 4/227 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Nervous system disorders Sciatica	1.8% 4/227 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	7.0% 16/227 • Number of events 17 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.2% 10/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	3.5% 8/227 • Number of events 9 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	0.42% 1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.8% 2/111 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	2.2% 5/227 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.0% 12/240 • Number of events 16 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Renal and urinary disorders Pollakiuria	1.3% 3/227 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	1.2% 3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	10.1% 23/227 • Number of events 27 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	11.2% 27/240 • Number of events 33 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	12.6% 14/111 • Number of events 18 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 9/227 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.9% 11/111 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.0% 12/240 • Number of events 22 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	6.3% 7/111 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 6/227 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.2% 10/240 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	3.1% 7/227 • Number of events 7 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.5% 6/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Ecchymosis	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	3.5% 8/227 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.9% 7/240 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.7% 3/111 • Number of events 3 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/227 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	7.5% 18/240 • Number of events 22 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.5% 5/111 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	7.0% 16/227 • Number of events 22 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	8.3% 20/240 • Number of events 24 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 11 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	18.5% 42/227 • Number of events 59 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	10.8% 26/240 • Number of events 31 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	14.4% 16/111 • Number of events 19 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.4% 10/227 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.3% 8/240 • Number of events 10 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 4 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.88% 2/227 • Number of events 2 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.8% 9/240 • Number of events 12 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	4.5% 5/111 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Haematoma	0.44% 1/227 • Number of events 1 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 13/240 • Number of events 18 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	5.4% 6/111 • Number of events 8 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Hypertension	8.4% 19/227 • Number of events 21 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	11.7% 28/240 • Number of events 36 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	9.0% 10/111 • Number of events 13 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.
Vascular disorders Hypotension	9.3% 21/227 • Number of events 25 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	2.5% 6/240 • Number of events 6 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.	3.6% 4/111 • Number of events 5 • All-cause mortality and adverse events (AEs): Up to approximately 3 years and 7 months (as of data cut-off date of 07MAY2021) All-cause mortality is reported for all randomized participants. Serious and other AEs include participants who received at least one dose of study drug.

Additional Information

Study Director

BeiGene

Phone: 1-877-828-5568

Email: clinicaltrials@beigene.com

Results disclosure agreements

• Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
• Publication restrictions are in place

Restriction type: OTHER