Trial Outcomes & Findings for An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) (NCT NCT02654132)

NCT ID: NCT02654132

Last Updated: 2022-11-01

Results Overview

PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 117 participants
• Primary outcome timeframe: From randomization to date of progression or death (up to approximately 21 months)
• Results posted on: 2022-11-01

Participant Flow

117 participants were randomized, and 115 participants were treated.

Participant milestones

Measure	E-Pd Cohort Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort Pomalidomide + Dexamethasone
Pre-Treatment Period STARTED	60	57
Pre-Treatment Period COMPLETED	60	55
Pre-Treatment Period NOT COMPLETED	0	2
Treatment Period STARTED	60	55
Treatment Period COMPLETED	0	0
Treatment Period NOT COMPLETED	60	55

Reasons for withdrawal

Measure	E-Pd Cohort Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort Pomalidomide + Dexamethasone
Pre-Treatment Period Participant Withdrew Consent	0	2
Treatment Period Disease progression	43	38
Treatment Period Adverse Event unrelated to study drug	6	9
Treatment Period Other reasons	4	2
Treatment Period Study drug toxicity	2	2
Treatment Period Withdrawal by Subject	2	1
Treatment Period Maximum Clinical Benefit	0	2
Treatment Period Participant request to discontinue	2	0
Treatment Period Administrative reasons by sponsor	0	1
Treatment Period Death	1	0

Baseline Characteristics

All treated participants

Baseline characteristics by cohort

Measure	E-Pd Cohort n=60 Participants Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=57 Participants Pomalidomide + Dexamethasone	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Age, Continuous	66.2 Years STANDARD_DEVIATION 9.92 • n=5 Participants	65.5 Years STANDARD_DEVIATION 9.95 • n=7 Participants	65.9 Years STANDARD_DEVIATION 9.90 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants • All treated participants	22 Participants n=7 Participants • All treated participants	50 Participants n=5 Participants • All treated participants
Sex: Female, Male Male	32 Participants n=5 Participants • All treated participants	35 Participants n=7 Participants • All treated participants	67 Participants n=5 Participants • All treated participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	49 Participants n=5 Participants	39 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized White	45 Participants n=5 Participants • All treated participants	45 Participants n=7 Participants • All treated participants	90 Participants n=5 Participants • All treated participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants • All treated participants	1 Participants n=7 Participants • All treated participants	1 Participants n=5 Participants • All treated participants
Race/Ethnicity, Customized Asian	15 Participants n=5 Participants • All treated participants	9 Participants n=7 Participants • All treated participants	24 Participants n=5 Participants • All treated participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants • All treated participants	2 Participants n=7 Participants • All treated participants	2 Participants n=5 Participants • All treated participants

PRIMARY outcome

Timeframe: From randomization to date of progression or death (up to approximately 21 months)

Population: All randomized participants

PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:

1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder

Outcome measures

Measure	E-Pd Cohort n=60 Participants Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=57 Participants Pomalidomide + Dexamethasone
Progression Free Survival (PFS)	10.25 Months Interval 6.54 to Upper limit not reached	4.70 Months Interval 2.83 to 7.62

SECONDARY outcome

Timeframe: From first dose to disease progression (up to approximately 21 months)

Population: All randomized participants

ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment

• CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow
• sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
• VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour
• PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.

Outcome measures

Measure	E-Pd Cohort n=60 Participants Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=57 Participants Pomalidomide + Dexamethasone
Objective Response Rate (ORR)	58.3 Percent of participants Interval 44.9 to 70.9	24.6 Percent of participants Interval 14.1 to 37.8

SECONDARY outcome

Timeframe: From randomization to death (up to approximately 52 months)

Population: All randomized participants

OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.

Outcome measures

Measure	E-Pd Cohort n=60 Participants Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=57 Participants Pomalidomide + Dexamethasone
Overall Survival (OS)	29.80 Months Interval 22.87 to 45.67	17.41 Months Interval 13.83 to 27.7

Adverse Events

E-Pd Cohort

Serious events: 42 serious events

Other events: 56 other events

Deaths: 41 deaths

Pd Cohort

Serious events: 33 serious events

Other events: 49 other events

Deaths: 41 deaths

Serious adverse events

Measure	E-Pd Cohort n=60 participants at risk Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=55 participants at risk Pomalidomide + Dexamethasone
Blood and lymphatic system disorders Anaemia	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Febrile neutropenia	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Thrombocytopenia	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Acute myocardial infarction	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Angina unstable	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Atrial fibrillation	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Atrial flutter	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Cardiac disorder	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Cardiac failure	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Cardiac disorders Myocardial infarction	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Eye disorders Cataract	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Eye disorders Cataract subcapsular	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Diverticular perforation	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Intestinal obstruction	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Disease progression	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Fatigue	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders General physical health deterioration	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Multiple organ dysfunction syndrome	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Non-cardiac chest pain	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Pyrexia	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Sudden death	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Immune system disorders Primary amyloidosis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Adenovirus infection	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Atypical pneumonia	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Bacterial sepsis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Bronchitis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Diverticulitis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Escherichia sepsis	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations H1N1 influenza	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Infection	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Lower respiratory tract infection	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pneumococcal sepsis	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pneumocystis jirovecii pneumonia	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pneumonia	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pneumonia influenzal	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Progressive multifocal leukoencephalopathy	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pseudomonal sepsis	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Respiratory syncytial virus infection	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Respiratory tract infection	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Sepsis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Septic shock	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Streptococcal bacteraemia	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Systemic infection	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Upper respiratory tract infection	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Wound infection	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Injury, poisoning and procedural complications Infusion related reaction	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Hypercalcaemia	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Bone pain	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	12.7% 7/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell leukaemia	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Cerebrovascular accident	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Haemorrhagic transformation stroke	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Presyncope	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Transient ischaemic attack	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Psychiatric disorders Confusional state	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Renal and urinary disorders Acute kidney injury	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Renal and urinary disorders Bladder prolapse	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Renal and urinary disorders Renal failure	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Asthma	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Vascular disorders Peripheral ischaemia	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants

Other adverse events

Measure	E-Pd Cohort n=60 participants at risk Elotuzumab + Pomalidomide + Dexamethasone	Pd Cohort n=55 participants at risk Pomalidomide + Dexamethasone
Blood and lymphatic system disorders Anaemia	28.3% 17/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	38.2% 21/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Leukopenia	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Lymphopenia	10.0% 6/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Neutropenia	26.7% 16/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	30.9% 17/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Blood and lymphatic system disorders Thrombocytopenia	15.0% 9/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	20.0% 11/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Eye disorders Cataract	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	0.00% 0/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Abdominal pain	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Constipation	23.3% 14/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	10.9% 6/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Diarrhoea	25.0% 15/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	12.7% 7/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Nausea	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Gastrointestinal disorders Stomatitis	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Asthenia	13.3% 8/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Fatigue	18.3% 11/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	14.5% 8/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Oedema peripheral	18.3% 11/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
General disorders Pyrexia	18.3% 11/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	21.8% 12/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Bronchitis	15.0% 9/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Influenza	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Nasopharyngitis	25.0% 15/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	16.4% 9/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Oral candidiasis	1.7% 1/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pharyngitis	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Pneumonia	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Respiratory tract infection	16.7% 10/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Upper respiratory tract infection	13.3% 8/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	16.4% 9/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Infections and infestations Urinary tract infection	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Investigations Blood creatinine increased	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	10.9% 6/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Investigations Neutrophil count decreased	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Investigations Platelet count decreased	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Investigations White blood cell count decreased	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Decreased appetite	10.0% 6/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Hypercalcaemia	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Hyperglycaemia	21.7% 13/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	20.0% 11/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Hypokalaemia	11.7% 7/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	12.7% 7/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Metabolism and nutrition disorders Hypomagnesaemia	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	12.7% 7/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Back pain	10.0% 6/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Bone pain	18.3% 11/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Muscle spasms	15.0% 9/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Muscular weakness	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Dizziness	3.3% 2/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Hypoaesthesia	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Neuropathy peripheral	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Polyneuropathy	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	1.8% 1/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Nervous system disorders Tremor	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Psychiatric disorders Depression	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	3.6% 2/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Psychiatric disorders Insomnia	16.7% 10/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	12.7% 7/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Cough	8.3% 5/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	9.1% 5/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 9/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 4/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	7.3% 4/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Skin and subcutaneous tissue disorders Rash	10.0% 6/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	10.9% 6/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Vascular disorders Hypertension	5.0% 3/60 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants	5.5% 3/55 • All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months) All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants

Additional Information

Bristol Myers-Squibb Study Director

Bristol Myers-Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER