Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091) (NCT NCT02504372)

NCT ID: NCT02504372

Last Updated: 2025-09-15

Results Overview

DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1177 participants
• Primary outcome timeframe: Up to approximately 84 months
• Results posted on: 2025-09-15

Participant Flow

One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Participant milestones

Measure	Pembrolizumab Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo Participants received placebo, IV, every 3 weeks, for one year.
Overall Study STARTED	590	587
Overall Study Treated	580	581
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	590	587

Reasons for withdrawal

Measure	Pembrolizumab Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo Participants received placebo, IV, every 3 weeks, for one year.
Overall Study Death	136	154
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal of consent	25	16
Overall Study Participants ongoing	429	415

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pembrolizumab n=590 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=587 Participants Participants received placebo, IV, every 3 weeks, for one year.	Total n=1177 Participants Total of all reporting groups
Age, Continuous	64.1 Years STANDARD_DEVIATION 8.5 • n=590 Participants	64.5 Years STANDARD_DEVIATION 8.4 • n=587 Participants	64.3 Years STANDARD_DEVIATION 8.4 • n=1177 Participants
Sex: Female, Male Female	189 Participants n=590 Participants	184 Participants n=587 Participants	373 Participants n=1177 Participants
Sex: Female, Male Male	401 Participants n=590 Participants	403 Participants n=587 Participants	804 Participants n=1177 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=590 Participants	0 Participants n=587 Participants	1 Participants n=1177 Participants
Race (NIH/OMB) Asian	107 Participants n=590 Participants	107 Participants n=587 Participants	214 Participants n=1177 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=590 Participants	0 Participants n=587 Participants	0 Participants n=1177 Participants
Race (NIH/OMB) Black or African American	0 Participants n=590 Participants	3 Participants n=587 Participants	3 Participants n=1177 Participants
Race (NIH/OMB) White	450 Participants n=590 Participants	455 Participants n=587 Participants	905 Participants n=1177 Participants
Race (NIH/OMB) More than one race	10 Participants n=590 Participants	3 Participants n=587 Participants	13 Participants n=1177 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=590 Participants	19 Participants n=587 Participants	41 Participants n=1177 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Disease Stage at Baseline Stage IB	85 Participants n=590 Participants	87 Participants n=587 Participants	172 Participants n=1177 Participants
Disease Stage at Baseline Stage II	330 Participants n=590 Participants	338 Participants n=587 Participants	668 Participants n=1177 Participants
Disease Stage at Baseline Stage IIIA	175 Participants n=590 Participants	160 Participants n=587 Participants	335 Participants n=1177 Participants
Disease Stage at Baseline Stage IV	0 Participants n=590 Participants	2 Participants n=587 Participants	2 Participants n=1177 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status at Baseline TPS <1%	233 Participants n=590 Participants	232 Participants n=587 Participants	465 Participants n=1177 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status at Baseline TPS 1-49%	189 Participants n=590 Participants	190 Participants n=587 Participants	379 Participants n=1177 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status at Baseline TPS ≥50%	168 Participants n=590 Participants	165 Participants n=587 Participants	333 Participants n=1177 Participants
Adjuvant Chemotherapy at Baseline Yes	506 Participants n=590 Participants	504 Participants n=587 Participants	1010 Participants n=1177 Participants
Adjuvant Chemotherapy at Baseline No	84 Participants n=590 Participants	83 Participants n=587 Participants	167 Participants n=1177 Participants
Geographic region Western Europe	303 Participants n=590 Participants	301 Participants n=587 Participants	604 Participants n=1177 Participants
Geographic region Eastern Europe	116 Participants n=590 Participants	113 Participants n=587 Participants	229 Participants n=1177 Participants
Geographic region Rest of the World	65 Participants n=590 Participants	68 Participants n=587 Participants	133 Participants n=1177 Participants
Geographic region Asia	106 Participants n=590 Participants	105 Participants n=587 Participants	211 Participants n=1177 Participants
Tumor Histology Squamous	192 Participants n=590 Participants	224 Participants n=587 Participants	416 Participants n=1177 Participants
Tumor Histology Non-squamous	398 Participants n=590 Participants	363 Participants n=587 Participants	761 Participants n=1177 Participants
Smoking status Never smoker	87 Participants n=590 Participants	66 Participants n=587 Participants	153 Participants n=1177 Participants
Smoking status Former smoker	428 Participants n=590 Participants	431 Participants n=587 Participants	859 Participants n=1177 Participants
Smoking status Current smoker	75 Participants n=590 Participants	90 Participants n=587 Participants	165 Participants n=1177 Participants

PRIMARY outcome

Timeframe: Up to approximately 84 months

Population: All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Outcome measures

Measure	Pembrolizumab n=590 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=587 Participants Participants received placebo, IV, every 3 weeks, for one year.
Disease-Free Survival (DFS)	53.8 Months Interval 46.2 to 67.0	43.0 Months Interval 35.0 to 51.6

PRIMARY outcome

Timeframe: Up to approximately 84 months

Population: All randomized PDL-1 strong positive participants with TPS ≥50%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

DFS in PDL-1 strong positive participants with TPS ≥50% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Outcome measures

Measure	Pembrolizumab n=168 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=165 Participants Participants received placebo, IV, every 3 weeks, for one year.
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%	67.0 Months Interval 47.8 to NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.	47.6 Months Interval 36.4 to NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 84 months

Population: All randomized PDL-1 strong positive participants with TPS ≥1%. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

DFS in PDL-1 strong positive participants with TPS ≥1% was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Outcome measures

Measure	Pembrolizumab n=357 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=355 Participants Participants received placebo, IV, every 3 weeks, for one year.
DFS in PDL-1 Strong Positive Participants With TPS ≥1%	58.7 Months Interval 46.2 to 76.7	42.8 Months Interval 35.0 to 57.8

SECONDARY outcome

Timeframe: Up to approximately 132 months

OS was defined as the time from randomization to the date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 132 months

OS in PDL-1 Strong Positive Participants with TPS ≥50% was defined as the time from randomization to the date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 132 months

OS in PDL-1 Strong Positive Participants with TPS ≥1% was defined as the time from randomization to the date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 132 months

LCSS was defined as the time from randomization to the date of death (due to lung cancer specifically).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 22 months

Population: All randomized participants who received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who experienced an AE were reported.

Outcome measures

Measure	Pembrolizumab n=580 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=581 Participants Participants received placebo, IV, every 3 weeks, for one year.
Number of Participants Who Experienced an Adverse Event (AE)	556 Participants	529 Participants

SECONDARY outcome

Timeframe: Up to approximately 19 months

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. The number of participants who discontinued study treatment due to an AE were reported.

Outcome measures

Measure	Pembrolizumab n=580 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=581 Participants Participants received placebo, IV, every 3 weeks, for one year.
Number of Participants Who Discontinued Study Treatment Due to an AE	116 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 68 months

Population: All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.

Outcome measures

Measure	Pembrolizumab n=590 Participants Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=587 Participants Participants received placebo, IV, every 3 weeks, for one year.
DFS at 68 Months	53.6 Months Interval 39.2 to NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.	42.0 Months Interval 31.3 to NA = Upper limit DFS was not reached at the time of last disease assessment due to insufficient number of participants with events.

Adverse Events

Pembrolizumab

Serious events: 142 serious events

Other events: 510 other events

Deaths: 136 deaths

Placebo

Serious events: 90 serious events

Other events: 458 other events

Deaths: 154 deaths

Serious adverse events

Measure	Pembrolizumab n=580 participants at risk Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=581 participants at risk Participants received placebo, IV, every 3 weeks, for one year.
Blood and lymphatic system disorders Anaemia	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Angina pectoris	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Atrial fibrillation	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Atrial tachycardia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Cardiac arrest	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Cardiac failure congestive	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Cardiogenic shock	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Coronary artery disease	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Myocardial infarction	0.34% 2/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.52% 3/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Myocardial ischaemia	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Myocarditis	0.86% 5/580 • Number of events 7 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Pericardial effusion	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Supraventricular tachycardia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Cardiac disorders Tachyarrhythmia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Adrenal insufficiency	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Glucocorticoid deficiency	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Hyperthyroidism	0.34% 2/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Hypophysitis	0.69% 4/580 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Hypothyroidism	0.34% 2/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Eye disorders Cataract	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Abdominal pain	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Colitis	0.69% 4/580 • Number of events 5 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Diarrhoea	1.2% 7/580 • Number of events 11 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Diverticular perforation	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Ileus paralytic	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Immune-mediated enterocolitis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Melaena	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Nausea	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Oesophagitis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Pancreatitis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Vomiting	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Asthenia	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Cardiac death	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Death	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Fatigue	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders General physical health deterioration	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Performance status decreased	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Pyrexia	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.52% 3/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Sudden death	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Autoimmune hepatitis	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Cholecystitis	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Cholecystitis acute	0.34% 2/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Hepatic failure	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Hepatic function abnormal	0.17% 1/580 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Hepatitis	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Hepatotoxicity	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Immune-mediated hepatitis	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Hepatobiliary disorders Jaundice	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Immune system disorders Anaphylactic shock	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Immune system disorders Hypersensitivity	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Immune system disorders Sarcoidosis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Appendicitis	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Atypical pneumonia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Bronchitis	0.52% 3/580 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations COVID-19	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations COVID-19 pneumonia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Clostridium difficile infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Cytomegalovirus infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Diverticulitis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Erysipelas	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Gastroenteritis	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Large intestine infection	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Lower respiratory tract infection	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Lower respiratory tract infection bacterial	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Penile infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Pneumocystis jirovecii pneumonia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Pneumonia	2.2% 13/580 • Number of events 15 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	1.5% 9/581 • Number of events 11 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Pneumonia bacterial	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Post procedural pneumonia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Pyelonephritis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Respiratory tract infection	0.17% 1/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Sepsis	0.52% 3/580 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.52% 3/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Septic shock	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Skin infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Staphylococcal sepsis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Upper respiratory tract infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Urinary tract infection	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Urosepsis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Vascular device infection	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Viral infection	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Ankle fracture	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Contusion	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Fall	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Hand fracture	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Hip fracture	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Incision site discharge	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Meniscus injury	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Poisoning	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Wound	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Wound dehiscence	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Injury, poisoning and procedural complications Wrist fracture	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Blood creatinine increased	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Troponin T increased	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Hyponatraemia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Arthralgia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Arthritis	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Back disorder	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Pathological fracture	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Sarcopenia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.34% 2/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Rash erythematous	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tracheal cancer	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Ataxia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Brain stem stroke	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Cerebral infarction	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Cerebral ischaemia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Cerebrovascular accident	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Dizziness	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Dysaesthesia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Dysarthria	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Intensive care unit acquired weakness	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Ischaemic stroke	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Retrograde amnesia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Superior sagittal sinus thrombosis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Syncope	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Transient ischaemic attack	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Product Issues Device dislocation	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Psychiatric disorders Completed suicide	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Psychiatric disorders Confusional state	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Psychiatric disorders Neurosis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Renal and urinary disorders Acute kidney injury	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Renal and urinary disorders Azotaemia	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Renal and urinary disorders Nephrolithiasis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Renal and urinary disorders Renal failure	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Renal and urinary disorders Urinary retention	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.86% 5/580 • Number of events 8 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.69% 4/580 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.69% 4/581 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.52% 3/580 • Number of events 5 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 12/580 • Number of events 15 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.69% 4/581 • Number of events 4 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.34% 2/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.52% 3/580 • Number of events 3 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Pruritus	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Urticaria	0.17% 1/580 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Aortic aneurysm	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Aortic aneurysm rupture	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 2 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Arterial thrombosis	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Giant cell arteritis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Hypertensive crisis	0.17% 1/580 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.00% 0/581 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Peripheral ischaemia	0.00% 0/580 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	0.17% 1/581 • Number of events 1 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Other adverse events

Measure	Pembrolizumab n=580 participants at risk Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.	Placebo n=581 participants at risk Participants received placebo, IV, every 3 weeks, for one year.
Endocrine disorders Hyperthyroidism	10.7% 62/580 • Number of events 65 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	2.9% 17/581 • Number of events 18 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Endocrine disorders Hypothyroidism	20.7% 120/580 • Number of events 148 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	4.6% 27/581 • Number of events 29 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Constipation	6.0% 35/580 • Number of events 38 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	7.1% 41/581 • Number of events 53 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Diarrhoea	17.9% 104/580 • Number of events 179 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	14.1% 82/581 • Number of events 160 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Gastrointestinal disorders Nausea	9.0% 52/580 • Number of events 64 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	6.4% 37/581 • Number of events 48 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Asthenia	7.6% 44/580 • Number of events 66 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 39 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Fatigue	16.6% 96/580 • Number of events 131 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	15.3% 89/581 • Number of events 118 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Influenza like illness	5.9% 34/580 • Number of events 39 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 36 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
General disorders Pyrexia	5.3% 31/580 • Number of events 34 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 48 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Nasopharyngitis	8.6% 50/580 • Number of events 65 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 44 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Infections and infestations Upper respiratory tract infection	9.0% 52/580 • Number of events 63 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	9.5% 55/581 • Number of events 68 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Alanine aminotransferase increased	7.9% 46/580 • Number of events 75 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.9% 34/581 • Number of events 42 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Aspartate aminotransferase increased	7.1% 41/580 • Number of events 61 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.3% 31/581 • Number of events 40 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Blood creatinine increased	6.6% 38/580 • Number of events 60 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 52 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Weight decreased	6.7% 39/580 • Number of events 59 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	4.3% 25/581 • Number of events 36 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Investigations Weight increased	22.8% 132/580 • Number of events 260 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	28.9% 168/581 • Number of events 314 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Metabolism and nutrition disorders Decreased appetite	7.1% 41/580 • Number of events 49 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	4.5% 26/581 • Number of events 28 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Arthralgia	18.4% 107/580 • Number of events 152 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	12.4% 72/581 • Number of events 99 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Back pain	7.8% 45/580 • Number of events 51 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	7.9% 46/581 • Number of events 57 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Myalgia	6.4% 37/580 • Number of events 47 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	2.6% 15/581 • Number of events 16 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 18/580 • Number of events 20 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.3% 31/581 • Number of events 38 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Headache	7.8% 45/580 • Number of events 67 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	7.9% 46/581 • Number of events 60 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Nervous system disorders Paraesthesia	3.1% 18/580 • Number of events 19 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.5% 32/581 • Number of events 39 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Cough	15.0% 87/580 • Number of events 101 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	16.9% 98/581 • Number of events 130 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.4% 66/580 • Number of events 87 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	12.4% 72/581 • Number of events 91 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.5% 32/580 • Number of events 52 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	2.6% 15/581 • Number of events 20 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Respiratory, thoracic and mediastinal disorders Productive cough	6.4% 37/580 • Number of events 46 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	2.6% 15/581 • Number of events 18 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Dry skin	5.3% 31/580 • Number of events 34 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	3.6% 21/581 • Number of events 25 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Pruritus	21.6% 125/580 • Number of events 167 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	12.7% 74/581 • Number of events 115 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Rash	8.4% 49/580 • Number of events 69 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	5.0% 29/581 • Number of events 37 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.4% 43/580 • Number of events 62 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	3.4% 20/581 • Number of events 27 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Vascular disorders Hypertension	11.6% 67/580 • Number of events 160 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.	12.7% 74/581 • Number of events 184 • Up to approximately 86 months All-cause mortality was reported on all randomized participants. Serious and non-serious adverse events were reported on all randomized participants who received at least one dose of study treatment. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 30 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER