Trial Outcomes & Findings for Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT02823574)

NCT ID: NCT02823574

Last Updated: 2023-05-03

Results Overview

ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 425 participants
• Primary outcome timeframe: Approximately up to 30 months (from FPFV to Data base lock)
• Results posted on: 2023-05-03

Participant Flow

425 randomized and 423 participants treated.

Participant milestones

Measure	Treatment A - Platinum Refractory Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Treatment A - Platinum Eligible Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Eligible Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Randomization STARTED	159	82	123	61
Randomization COMPLETED	158	82	122	61
Randomization NOT COMPLETED	1	0	1	0
Treatment Period STARTED	158	82	122	61
Treatment Period COMPLETED	0	0	0	0
Treatment Period NOT COMPLETED	158	82	122	61

Reasons for withdrawal

Measure	Treatment A - Platinum Refractory Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Treatment A - Platinum Eligible Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Eligible Subgroup Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Randomization Disease Progression	0	0	1	0
Randomization AE unrelated to Study Drug	1	0	0	0
Treatment Period Poor/Non Compliance	1	0	0	1
Treatment Period Maximum Clinical Benefit	8	4	7	1
Treatment Period Lost to Follow-up	1	1	0	0
Treatment Period Participant withdrew consent	4	0	0	1
Treatment Period Participant request to discontinue	5	0	3	2
Treatment Period Adverse Event unrelated to to study Drug	10	2	9	2
Treatment Period Study Drug Toxicity	11	2	14	4
Treatment Period Disease Progression	113	64	82	43
Treatment Period Other reasons	5	9	3	6
Treatment Period Participant no longer meets study criteria	0	0	1	0
Treatment Period Death	0	0	3	1

Baseline Characteristics

All Randomized Participants is the total of the 2 subgroups

Baseline characteristics by cohort

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Treatment A - Platinum Eligible Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Eligible Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Total n=425 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Age, Categorical Between 18 and 65 years	119 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	63 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	79 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	40 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	301 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Age, Categorical >=65 years	40 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	19 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	44 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	21 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	124 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Sex: Female, Male Female	29 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	18 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	18 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	14 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	79 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Sex: Female, Male Male	130 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	64 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	105 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	47 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	346 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	7 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	6 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	6 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	29 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	23 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	66 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	25 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	170 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Ethnicity (NIH/OMB) Unknown or Not Reported	93 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	52 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	51 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	30 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	226 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) Asian	3 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	1 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	1 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	5 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	3 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	2 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	1 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	8 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) White	141 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	75 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	120 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	58 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	394 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	0 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	3 Participants n=7 Participants • All Randomized Participants is the total of the 2 subgroups	1 Participants n=5 Participants • All Randomized Participants is the total of the 2 subgroups	1 Participants n=4 Participants • All Randomized Participants is the total of the 2 subgroups	18 Participants n=21 Participants • All Randomized Participants is the total of the 2 subgroups

PRIMARY outcome

Timeframe: Approximately up to 30 months (from FPFV to Data base lock)

Population: All Randomized Participants - Platinum Refractory Subgroup

ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup	13.2 percentage of participants Interval 8.4 to 19.5	18.3 percentage of participants Interval 10.6 to 28.4

PRIMARY outcome

Timeframe: Approximately up to 30 months (from FPFV to Data base lock)

Population: Platinum Refractory Responders

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=21 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=15 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup	NA Months Interval 11.01 to Insufficient number of events for median, upper limit not calculable	11.07 Months Interval 4.14 to upper limit not calculable

PRIMARY outcome

Timeframe: Approximately up to 30 months (from FPFV to Data base lock)

Population: Platinum refractory responders

Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=21 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=15 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup	2.56 Months Interval 1.1 to 6.6	1.51 Months Interval 1.2 to 7.7

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

ORR is defined as percentage of participants with a complete response (CR) or partial response (PR).

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup	20.3 percentage of participants Interval 13.6 to 28.5	29.5 percentage of participants Interval 18.5 to 42.6

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum eligible subgroup responders

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=25 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=18 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup	27.04 Months Interval 11.01 to Insufficient number of events for median, upper limit not calculable	24.61 Months Interval 6.9 to Insufficient number of events for median, upper limit not calculable

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Refractory subgroup all randomized

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup	2.50 Months Interval 1.45 to 2.76	2.60 Months Interval 1.54 to 3.38

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Eligible subgroup all randomized

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup	2.76 Months Interval 1.64 to 4.17	2.86 Months Interval 1.51 to 5.65

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=282 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=143 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS)	9.76 Months Interval 7.52 to 11.47	11.30 Months Interval 8.48 to 14.0

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Refractory Subgroup	9.76 Months Interval 6.51 to 11.37	9.59 Months Interval 7.13 to 14.26

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Eligible Subgroup	9.71 Months Interval 7.43 to 12.62	12.91 Months Interval 9.33 to 22.01

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Eligible Subgroup Based on HPV p-16 Status Positive	20.0 percentage of participants Interval 8.4 to 36.9	41.2 percentage of participants Interval 18.4 to 67.1
ORR - Platinum Eligible Subgroup Based on HPV p-16 Status Negative	20.5 percentage of participants Interval 12.6 to 30.4	25.0 percentage of participants Interval 13.2 to 40.3

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB < 7	10.2 percentage of participants Interval 3.8 to 20.8	30.8 percentage of participants Interval 14.3 to 51.8
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB ≥ 7	34.2 percentage of participants Interval 19.6 to 51.4	28.6 percentage of participants Interval 11.3 to 52.2
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB < 10	17.3 percentage of participants Interval 9.8 to 27.3	28.6 percentage of participants Interval 14.6 to 46.3
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB ≥ 10	31.3 percentage of participants Interval 11.0 to 58.7	33.3 percentage of participants Interval 9.9 to 65.1
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB Not Reported	23.1 percentage of participants Interval 9.0 to 43.6	28.6 percentage of participants Interval 8.4 to 58.1

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Refractory Subgroup Based on HPV p-16 Status OROPHARYNGEAL HPV P-16 POSITIVE	23.3 percentage of participants Interval 9.9 to 42.3	37.5 percentage of participants Interval 15.2 to 64.6
ORR - Platinum Refractory Subgroup Based on HPV p-16 Status OROPHARYNGEAL HPV P-16 NEGATIVE/ NON-OROPHARYNGEAL	12.4 percentage of participants Interval 7.3 to 19.4	16.7 percentage of participants Interval 8.6 to 27.9

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB < 7	9.0 percentage of participants Interval 3.4 to 18.5	20.5 percentage of participants Interval 9.3 to 36.5
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB ≥ 7	23.3 percentage of participants Interval 11.8 to 38.6	19.0 percentage of participants Interval 5.4 to 41.9
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB < 10	11.0 percentage of participants Interval 5.4 to 19.3	22.4 percentage of participants Interval 11.8 to 36.6
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB ≥ 10	31.6 percentage of participants Interval 12.6 to 56.6	18.2 percentage of participants Interval 2.3 to 51.8
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker TMB Not Reported	14.3 percentage of participants Interval 5.9 to 27.2	18.2 percentage of participants Interval 5.2 to 40.3

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: All treated participants in the Platinum Refractory subgroup with a response

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=21 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=15 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status HPV p-16 Negative	39.43 Months Interval 26.71 to Insufficient number of events to calculate upper limit number.	8.34 Months Interval 2.79 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status HPV p-16 Positive	NA Months Interval 6.87 to Insufficient number of events to calculate median and upper limit number.	11.10 Months Interval 4.17 to 14.9

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: All treated participants in the Platinum Refractory subgroup with a response

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=21 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=15 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <7	NA Months Interval 11.01 to Insufficient number of events to calculate median and upper limit number.	11.14 Months Interval 2.69 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB ≥ 7	38.67 Months Interval 3.06 to 39.43	8.59 Months Interval 2.79 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <10	NA Months Interval 3.06 to Insufficient number of events to calculate upper limit number and median	11.14 Months Interval 4.17 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 10	38.67 Months Interval 6.87 to 38.67	7.54 Months Interval 2.79 to 12.29
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: Not Reported	26.71 Months Interval 6.93 to 26.71	8.21 Months Interval 4.14 to 14.29

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Refractory subgroup all randomized

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status Postive	4.11 Months Interval 1.81 to 8.31	6.70 Months Interval 1.28 to 13.67
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status Negative	1.84 Months Interval 1.41 to 2.63	1.94 Months Interval 1.41 to 3.02

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Refractory subgroup all randomized

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 7	1.45 Months Interval 1.38 to 2.6	2.50 Months Interval 1.41 to 5.26
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 7	2.76 Months Interval 1.45 to 4.11	1.54 Months Interval 1.25 to 4.07
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 10	1.68 Months Interval 1.41 to 2.6	2.50 Months Interval 1.41 to 4.24
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 10	2.81 Months Interval 1.38 to 9.69	1.41 Months Interval 1.25 to 4.07
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: Not Reported	2.66 Months Interval 1.45 to 2.92	2.92 Months Interval 1.28 to 7.0

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status Positive	13.93 Months Interval 5.98 to 33.81	14.32 Months Interval 6.28 to 44.88
Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status Negative	9.36 Months Interval 5.98 to 10.87	9.59 Months Interval 6.93 to 13.4

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <7	5.78 Months Interval 3.45 to 9.76	8.77 Months Interval 4.14 to 16.66
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 7	11.37 Months Interval 6.41 to 16.95	7.16 Months Interval 6.28 to 12.29
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 10	7.52 Months Interval 4.96 to 11.27	8.31 Months Interval 4.9 to 13.04
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥10	6.51 Months Interval 2.5 to 41.33	9.26 Months Interval 1.35 to 17.51
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status Not Reported	13.86 Months Interval 9.53 to 17318.0	20.01 Months Interval 7.56 to 23.46

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status Positive	16.66 Months Interval 8.54 to 28.06	33.74 Months Interval 12.91 to Insufficient number of events to calculate upper limit number.
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status Negative	7.79 Months Interval 5.06 to 12.39	9.46 Months Interval 5.32 to 14.0

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: All Randomized Participants - Platinum Eligible Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <7	7.56 Months Interval 4.83 to 12.25	18.27 Months Interval 4.04 to 33.74
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 7	16.30 Months Interval 9.43 to 36.3	13.08 Months Interval 8.28 to 38.11
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 10	9.99 Months Interval 6.41 to 12.62	15.01 Months Interval 7.62 to 27.47
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥10	16.72 Months Interval 4.47 to upper limit not calculable	14.77 Months Interval 2.83 to upper limit not calculable
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status Not Reported	8.00 Months Interval 3.84 to 26.12	9.71 Months Interval 2.56 to 18.79

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum eligible subgroup all randomized

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 7	2.63 Months Interval 1.45 to 3.06	2.92 Months Interval 1.38 to 9.59
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 7	5.82 Months Interval 1.45 to 12.42	2.83 Months Interval 1.41 to 13.01
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: < 10	2.63 Months Interval 1.45 to 3.06	2.99 Months Interval 1.41 to 13.01
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 10	6.97 Months Interval 1.41 to Insufficient number of events to calculate upper limit number.	2.76 Months Interval 0.72 to 27.6
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: Not Reported	2.71 Months Interval 1.45 to 8.48	3.10 Months Interval 1.38 to 9.82

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum eligible subgroup

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status Postive	2.92 Months Interval 1.41 to 6.6	6.83 Months Interval 1.38 to 49.84
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status Negative	2.66 Months Interval 1.51 to 4.14	2.83 Months Interval 1.51 to 4.24

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: All treated participants in the Platinum Eligible subgroup with a response

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=25 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=18 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status Positive	33.84 Months Interval 4.14 to Insufficient number of events to calculate upper limit number.	48.49 Months Interval 5.49 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status Negative	27.04 Months Interval 10.97 to Insufficient number of events to calculate upper limit number.	19.32 Months Interval 4.11 to Insufficient number of events to calculate upper limit number.

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: All treated participants in the Platinum eligible subgroup with a response

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=25 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=18 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <7	10.97 Months Interval 4.14 to 35.55	NA Months Interval 5.52 to Insufficient number of events to calculate upper limit number and median
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB ≥ 7	24.11 Months Interval 10.97 to Insufficient number of events to calculate upper limit number.	19.32 Months Interval 5.49 to 24.61
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: <10	13.67 Months Interval 8.28 to 35.55	NA Months Interval 5.52 to Insufficient number of events to calculate upper limit number and median
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: ≥ 10	NA Months Interval 5.78 to Insufficient number of events to calculate upper limit number and median	19.32 Months Interval 5.49 to 24.61
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status TMB: Not Reported	NA Months Interval 27.04 to Insufficient number of events to calculate upper limit number and median.	48.49 Months Interval 4.11 to Insufficient number of events to calculate upper limit number.

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: All treated participants in the Platinum refractory subgroup with a response

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=21 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=15 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	39.43 Months Interval 11.01 to Insufficient number of events to calculate upper limit number.	8.34 Months Interval 2.79 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: < 25%	39.43 Months Interval 6.87 to Insufficient number of events to calculate upper limit number.	11.10 Months Interval 4.17 to 38.51
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	NA Months Interval 6.93 to Insufficient number of events to calculate upper limit number and median	8.34 Months Interval 2.79 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: <50%	NA Months Interval 26.71 to Insufficient number of events to calculate upper limit number and median	11.14 Months Interval 4.17 to 38.51
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: > 50%	NA Months Interval 6.93 to Insufficient number of events to calculate upper limit number and median	6.24 Months Interval 4.14 to 8.34
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	39.43 Months Interval 3.06 to 39.43	NA Months Interval 4.17 to Insufficient number of events to calculate upper limit number and median
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: Unquantifiable	38.67 Months Insufficient number of events to calculate upper limit number and lower limit number	—

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: Platinum Refractory subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression <1%	7.7 Percentage of Participants Interval 2.1 to 18.5	25.8 Percentage of Participants Interval 11.9 to 44.6
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: ≥ 1%	19.6 Percentage of Participants Interval 12.0 to 29.1	19.6 Percentage of Participants Interval 9.4 to 33.9
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: < 25%	11.1 Percentage of Participants Interval 6.1 to 18.3	21.1 Percentage of Participants Interval 11.4 to 33.9
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: ≥ 25%	33.3 Percentage of Participants Interval 16.5 to 54.0	25.0 Percentage of Participants Interval 8.7 to 49.1
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: <50%	13.2 Percentage of Participants Interval 7.9 to 20.3	22.7 Percentage of Participants Interval 13.3 to 34.7
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: > 50%	33.3 Percentage of Participants Interval 11.8 to 61.6	18.2 Percentage of Participants Interval 2.3 to 51.8
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression PD-L1: 1 - < 25%	13.8 Percentage of Participants Interval 6.5 to 24.7	15.4 Percentage of Participants Interval 4.4 to 34.9
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression without quantifiable PD-L1 expression at baseline	NA Percentage of Participants Not reported when sample size is less than 10 subjects for the subgroup category	NA Percentage of Participants Not reported when sample size is less than 10 subjects for the subgroup category

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: Platinum refractory subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	5.78 Months Interval 2.43 to 48.69	10.23 Months Interval 7.03 to 16.66
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: <50%	9.76 Months Interval 6.51 to 11.37	10.61 Months Interval 6.74 to 14.26
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: > 50%	26.02 Months Interval 2.43 to 48.69	7.33 Months Interval 1.51 to 16.66
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status <1%	9.53 Months Interval 6.31 to 12.62	12.29 Months Interval 6.08 to 20.27
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	10.22 Months Interval 5.95 to 14.52	9.02 Months Interval 6.74 to 13.34
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: < 25%	9.95 Months Interval 7.26 to 11.37	8.77 Months Interval 6.28 to 14.78
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	10.32 Months Interval 5.98 to 14.32	7.56 Months Interval 4.86 to 17.51
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status Without quantifiable PD-L1 expression at baseline	6.93 Months Interval 1.71 to 14.16	28.09 Months Interval 7.56 to 44.88

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Refractory subgroup

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	2.60 Months Interval 1.45 to 2.83	2.60 Months Interval 1.41 to 4.11
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: < 25%	2.60 Months Interval 1.45 to 2.83	2.79 Months Interval 1.41 to 4.01
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	2.12 Months Interval 1.38 to 13.77	1.54 Months Interval 1.25 to 7.03
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: <50%	2.60 Months Interval 1.45 to 2.79	2.79 Months Interval 1.54 to 4.07
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: > 50%	2.79 Months Interval 0.59 to 13.77	1.54 Months Interval 0.66 to 7.03
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	2.66 Months Interval 1.45 to 2.83	2.60 Months Interval 1.38 to 4.07
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status Without Quantifiable PD-L1 expression at Baseline	2.17 Months Interval 1.08 to 2.66	1.71 Months Interval 1.22 to insufficient number of participants with an event to calculate
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status <1%	2.60 Months Interval 1.41 to 2.86	2.96 Months Interval 1.38 to 5.32

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Eligible Responders

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=25 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=18 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	33.84 Months Interval 8.28 to Insufficient number of events to calculate upper limit number.	24.61 Months Interval 4.11 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: < 25%	13.17 Months Interval 4.17 to 35.55	12.42 Months Interval 4.11 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	NA Months Interval 8.28 to Insufficient number of events to calculate upper limit number and median	NA Months Interval 24.61 to Insufficient number of events to calculate upper limit number and median
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: <50%	13.67 Months Interval 5.78 to 35.55	15.87 Months Interval 4.11 to Insufficient number of events to calculate upper limit number.
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: > 50%	NA Months Interval 33.84 to Insufficient number of events to calculate upper limit number and median	NA Months Interval 24.61 to Insufficient number of events to calculate upper limit number and median
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	13.13 Months Interval 4.14 to Insufficient number of events to calculate upper limit number.	6.21 Months Interval 4.11 to 12.42
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: Unquantifiable	NA Months Interval 27.04 to Insufficient number of events to calculate upper limit number and median	28.99 Months Interval 9.49 to 48.49

SECONDARY outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: Platinum Eligible Subgroup

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression <1%	15.7 percentage of participants Interval 7.0 to 28.6	21.7 percentage of participants Interval 7.5 to 43.7
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: ≥ 1%	21.5 percentage of participants Interval 12.3 to 33.5	30.3 percentage of participants Interval 15.6 to 48.7
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: < 25%	14.9 percentage of participants Interval 8.2 to 24.2	24.3 percentage of participants Interval 11.8 to 41.2
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: ≥ 25%	31.0 percentage of participants Interval 15.3 to 50.8	31.6 percentage of participants Interval 12.6 to 56.6
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: <50%	16.7 percentage of participants Interval 9.8 to 25.6	24.4 percentage of participants Interval 12.4 to 40.3
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: > 50%	30.0 percentage of participants Interval 11.9 to 54.3	33.3 percentage of participants Interval 11.8 to 61.6
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression PD-L1: 1 - < 25%	13.9 percentage of participants Interval 4.7 to 29.5	28.6 percentage of participants Interval 8.4 to 58.1
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression Without quantifiable PD-L1 expression at baseline	NA percentage of participants Not reported when sample size is less than 10 subjects for the subgroup category,CI not calculable	NA percentage of participants Not reported when sample size is less than 10 subjects for the subgroup category, CI not calculable

SECONDARY outcome

Timeframe: From randomization to death. Approximately 63 Months

Population: Platinum Eligible Subgroup

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	12.39 months Interval 5.06 to 36.3	14.00 months Interval 6.34 to 38.74
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status Without quantifiable PD-L1 expression at baseline	26.12 months Interval 1.64 to Insufficient number of events to calculate upper limit number.	33.74 months Interval 5.72 to Insufficient number of events to calculate upper limit number.
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status <1%	12.52 months Interval 8.21 to 17.68	11.17 months Interval 3.42 to 21.52
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	7.56 months Interval 5.06 to 11.24	14.00 months Interval 7.62 to 23.66
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: < 25%	8.72 months Interval 5.91 to 12.25	11.17 months Interval 5.32 to 21.52
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: <50%	9.10 months Interval 6.57 to 12.62	9.92 months Interval 4.04 to 18.79
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: > 50%	9.40 months Interval 4.11 to 36.3	15.01 months Interval 7.62 to Insufficient number of events to calculate upper limit number.
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	6.16 months Interval 4.57 to 8.11	8.48 months Interval 2.83 to 22.41

SECONDARY outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum eligible subgroup

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=123 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=61 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status <1%	2.61 Months Interval 1.38 to 5.78	2.73 Months Interval 1.41 to 9.82
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 1%	2.89 Months Interval 1.51 to 4.21	2.99 Months Interval 1.38 to 5.65
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: < 25%	2.37 Months Interval 1.41 to 2.76	2.76 Months Interval 1.41 to 5.65
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: ≥ 25%	5.75 Months Interval 3.71 to 16.59	2.99 Months Interval 1.38 to Insufficient number of events to calculate upper limit number.
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: <50%	2.55 Months Interval 1.45 to 2.89	2.76 Months Interval 1.41 to 5.65
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: > 50%	4.21 Months Interval 2.79 to Insufficient number of events to calculate upper limit number.	2.99 Months Interval 1.38 to Insufficient number of events to calculate upper limit number.
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status PD-L1: 1 - < 25%	1.51 Months Interval 1.41 to 2.86	3.10 Months Interval 1.28 to 8.28
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status Without quantifiable PD-L1 expression at baseline	6.47 Months Interval 1.51 to Insufficient number of events to calculate upper limit number.	13.73 Months Interval 1.28 to 49.84

POST_HOC outcome

Timeframe: From randomization to end of study. Approximately 63 Months

Population: All Randomized Participants - Platinum Refractory Subgroup

ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=159 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis	14.5 percentage of participants Interval 9.4 to 20.9	20.7 percentage of participants Interval 12.6 to 31.1

POST_HOC outcome

Timeframe: From randomization to disease progression or death. Approximately 63 Months

Population: Platinum Refractory Responders

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=23 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=17 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis	39.43 Months Interval 26.71 to Upper Limit not calculable	11.07 Months Interval 4.17 to 38.51

POST_HOC outcome

Timeframe: From randomization to a confirmed response. Approximately 35 Months

Population: Platinum refractory responders

Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Treatment A - Platinum Refractory Subgroup n=23 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=17 Participants Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis	2.63 Months Interval 1.1 to 34.3	1.71 Months Interval 1.2 to 7.7

Adverse Events

Treatment A - Platinum Refractory Subgroup

Serious events: 103 serious events

Other events: 139 other events

Deaths: 131 deaths

Treatment B - Platinum Refractory Subgroup

Serious events: 52 serious events

Other events: 76 other events

Deaths: 71 deaths

Treatment A - Platinum Eligible Subgroup

Serious events: 89 serious events

Other events: 118 other events

Deaths: 102 deaths

Treatment B - Platinum Eligible Subgroup

Serious events: 35 serious events

Other events: 54 other events

Deaths: 49 deaths

Serious adverse events

Measure	Treatment A - Platinum Refractory Subgroup n=158 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Treatment A - Platinum Eligible Subgroup n=122 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Eligible Subgroup n=61 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Blood and lymphatic system disorders Anaemia	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Febrile bone marrow aplasia	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Lymph node pain	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Neutropenia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Acute myocardial infarction	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Arrhythmia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac arrest	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac failure congestive	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Myocardial infarction	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Pericardial effusion	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Vestibular disorder	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Adrenal insufficiency	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypophysitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal distension	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Ascites	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Autoimmune colitis	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Colitis	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Duodenitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dysphagia	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastric ulcer	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haematemesis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Hernial eventration	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Immune-mediated enterocolitis	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Mouth haemorrhage	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Mouth ulceration	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Oesophageal fistula	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Palatal disorder	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Pancreatitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal perforation	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Stomatitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	3.8% 6/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chest pain	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Death	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Drug intolerance	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Face oedema	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders General physical health deterioration	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Generalised oedema	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Hyperthermia	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Impaired healing	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Inflammation	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Mucosal inflammation	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pain	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Sudden death	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Swelling	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholecystitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Hepatotoxicity	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Drug hypersensitivity	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Abscess neck	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bacteraemia	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Empyema	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Encephalitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Endocarditis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Epiglottitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Focal peritonitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Gastroenteritis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Hepatic infection bacterial	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Herpes zoster	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Infective myositis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Influenza	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Lower respiratory tract infection	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Ludwig angina	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Lymph node abscess	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Neutropenic sepsis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Oral infection	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumococcal sepsis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	11.4% 18/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 10/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia aspiration	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia pseudomonal	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sepsis	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sepsis syndrome	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Septic shock	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sinusitis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Skin infection	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Staphylococcal bacteraemia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Staphylococcal scalded skin syndrome	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Subcutaneous abscess	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Tracheitis	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Tracheobronchitis	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Tracheostomy infection	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Vascular access site infection	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Viral myocarditis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Viral upper respiratory tract infection	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Femur fracture	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Foot fracture	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Hand fracture	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Head injury	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Overdose	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Spinal compression fracture	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Toxicity to various agents	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Vasoplegia syndrome	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Creatinine renal clearance decreased	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Platelet count decreased	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight decreased	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Dehydration	2.5% 4/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Failure to thrive	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Feeding disorder	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypercalcaemia	3.8% 6/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Malnutrition	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pathological fracture	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	38.6% 61/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	30.5% 25/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	38.5% 47/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	26.2% 16/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Carotid aneurysm rupture	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebral ischaemia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Cerebrovascular accident	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ischaemic stroke	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Nervous system disorder	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neuropathy peripheral	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues Device dislocation	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues Device leakage	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Renal failure	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Autoimmune lung disease	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 4/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 3/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal dyspnoea	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Embolism	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Haemorrhage	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypovolaemic shock	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Lymphoedema	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Peripheral venous disease	0.00% 0/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Superior vena cava syndrome	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Measure	Treatment A - Platinum Refractory Subgroup n=158 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Refractory Subgroup n=82 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W	Treatment A - Platinum Eligible Subgroup n=122 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W	Treatment B - Platinum Eligible Subgroup n=61 participants at risk Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy. Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Blood and lymphatic system disorders Anaemia	25.9% 41/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	40.2% 33/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.6% 30/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.6% 15/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Lymphopenia	7.6% 12/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hyperthyroidism	7.6% 12/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 11/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	17.7% 28/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.2% 10/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.9% 23/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	19.7% 12/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	5.1% 8/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 10/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	4.4% 7/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 4/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	15.2% 24/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.1% 14/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.3% 26/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 9/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	20.9% 33/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.7% 17/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.1% 27/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	24.6% 15/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dry mouth	7.0% 11/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dyspepsia	3.8% 6/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dysphagia	10.1% 16/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.2% 10/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 18/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.5% 7/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	19.6% 31/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	22.0% 18/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	23.0% 28/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	21.3% 13/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Stomatitis	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 6/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	11.4% 18/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.5% 14/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	17.1% 27/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	17.1% 14/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	10.7% 13/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.5% 7/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chills	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Face oedema	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	18.4% 29/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.6% 21/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	37.7% 46/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	36.1% 22/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Mucosal inflammation	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	4.4% 7/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 10/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	9.5% 15/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 15/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 6/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Oral candidiasis	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.82% 1/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	6.3% 10/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.3% 2/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	0.63% 1/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	5.1% 8/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 6/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Amylase increased	2.5% 4/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 10/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 11/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood alkaline phosphatase increased	4.4% 7/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood creatinine increased	7.0% 11/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.2% 10/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood thyroid stimulating hormone increased	2.5% 4/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lipase increased	8.2% 13/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 11/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight decreased	12.7% 20/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.5% 25/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	13.3% 21/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.7% 17/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	20.5% 25/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.1% 8/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypercalcaemia	11.4% 18/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.2% 10/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 11/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	3.2% 5/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperkalaemia	4.4% 7/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	3.2% 5/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 12/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypomagnesaemia	5.1% 8/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 9/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 6/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	7.0% 11/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.5% 14/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	12.7% 20/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 18/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.4% 10/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	6.3% 10/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 12/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Myalgia	3.2% 5/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 3/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	11.4% 18/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.7% 7/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 9/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	5.1% 8/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	8.9% 14/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.0% 11/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 6/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Anxiety	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 2/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	8.2% 13/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.2% 5/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	12.7% 20/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.4% 20/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 9/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.8% 17/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.4% 20/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.8% 9/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Productive cough	5.7% 9/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 6/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.5% 7/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Dry skin	6.3% 10/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 6/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Erythema	1.9% 3/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 8/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.6% 1/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	20.9% 33/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	19.7% 24/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.4% 10/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	20.3% 32/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.0% 9/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	15.6% 19/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 6/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	1.3% 2/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.6% 4/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypotension	3.8% 6/158 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.1% 5/122 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 6/61 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: Clinical.Trials@bms.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60