Trial Outcomes & Findings for Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan (NCT NCT02272803)

NCT ID: NCT02272803

Last Updated: 2022-06-22

Results Overview

ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 82 participants
• Primary outcome timeframe: From first dose until documented response (assessed up to February 2017, approximately 24 months)
• Results posted on: 2022-06-22

Participant Flow

82 participants were randomized and treated.

Participant milestones

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Overall Study STARTED	40	42
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	40	42

Reasons for withdrawal

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Overall Study Disease progression	16	8
Overall Study Adverse Event unrelated to study drug	3	5
Overall Study Study drug toxicity	4	9
Overall Study Participant request to discontinue study treatment	3	7
Overall Study Maximum clinical benefit	4	2
Overall Study Poor/non-compliance	2	2
Overall Study Withdrawal by Subject	2	1
Overall Study Death	0	1
Overall Study Other reasons	1	3
Overall Study Administrative reason by sponsor	5	4

Baseline Characteristics

All treated participants

Baseline characteristics by cohort

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 Participants Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 Participants Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle	Total n=82 Participants Total of all reporting groups
Age, Continuous	72.6 years STANDARD_DEVIATION 4.91 • n=5 Participants • All treated participants	74.0 years STANDARD_DEVIATION 6.32 • n=7 Participants • All treated participants	73.3 years STANDARD_DEVIATION 5.69 • n=5 Participants • All treated participants
Sex: Female, Male Female	23 Participants n=5 Participants • All treated participants	20 Participants n=7 Participants • All treated participants	43 Participants n=5 Participants • All treated participants
Sex: Female, Male Male	17 Participants n=5 Participants • All treated participants	22 Participants n=7 Participants • All treated participants	39 Participants n=5 Participants • All treated participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants
Race (NIH/OMB) Asian	40 Participants n=5 Participants • All treated participants	42 Participants n=7 Participants • All treated participants	82 Participants n=5 Participants • All treated participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants
Race (NIH/OMB) White	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All treated participants	0 Participants n=7 Participants • All treated participants	0 Participants n=5 Participants • All treated participants

PRIMARY outcome

Timeframe: From first dose until documented response (assessed up to February 2017, approximately 24 months)

Population: Participants treated with E-Ld

ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.

SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 Participants Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)	87.5 Percentage of participants Interval 79.7 to 92.9	—

SECONDARY outcome

Timeframe: From first dose until documented response, up to approximately 72 months

Population: All randomized participants

ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.

SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 Participants Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 Participants Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Objective Response Rate (ORR)	92.5 Percentage of participants Interval 79.6 to 98.4	73.8 Percentage of participants Interval 58.0 to 86.1

SECONDARY outcome

Timeframe: From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months

Population: All randomized participants

PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.

Outcome measures

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 Participants Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 Participants Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Progression Free Survival (PFS)	NA Months Interval 23.1 to Median and upper limit were not estimable due to an insufficient number of participants with events.	43.33 Months Interval 16.66 to Upper limit was not estimable due to an insufficient number of participants with events.

SECONDARY outcome

Timeframe: From randomization up to the specified timepoints, up to 3 years

Population: All randomized participants

PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints

Outcome measures

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 Participants Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 Participants Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Progression Free Survival (PFS) Rate 1 year	0.87 Percentage of Participants Interval 0.72 to 0.95	0.89 Percentage of Participants Interval 0.73 to 0.96
Progression Free Survival (PFS) Rate 2 years	0.67 Percentage of Participants Interval 0.49 to 0.8	0.60 Percentage of Participants Interval 0.41 to 0.75
Progression Free Survival (PFS) Rate 3 years	0.61 Percentage of Participants Interval 0.42 to 0.75	0.56 Percentage of Participants Interval 0.36 to 0.71

Adverse Events

Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)

Serious events: 26 serious events

Other events: 39 other events

Deaths: 2 deaths

Arm B: Lenalidomide + Dexamethasone

Serious events: 27 serious events

Other events: 42 other events

Deaths: 6 deaths

Serious adverse events

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 participants at risk Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 participants at risk Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Blood and lymphatic system disorders Agranulocytosis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Cardiac disorders Cardiac failure	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Cardiac disorders Cardiac failure acute	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Cardiac disorders Cardiac failure congestive	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Cardiac disorders Eosinophilic myocarditis	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Eye disorders Cataract	17.5% 7/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	16.7% 7/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Eye disorders Cataract subcapsular	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Dental caries	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Enterocolitis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Ileus paralytic	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Inguinal hernia	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Intestinal perforation	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Ischaemic enteritis	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Stomatitis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Chills	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Fatigue	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Generalised oedema	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Pyrexia	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Sudden death	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Hepatobiliary disorders Bile duct stone	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Hepatobiliary disorders Cholecystitis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Disseminated varicella zoster virus infection	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Gastroenteritis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Herpes zoster	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Influenza	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Osteomyelitis	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Peri-implantitis	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Peritonitis	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Pneumonia	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	16.7% 7/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Pneumonia cryptococcal	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Pneumonia influenzal	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Sepsis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Urinary tract infection	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Compression fracture	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Fall	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Femur fracture	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Fracture	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Humerus fracture	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Near drowning	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Spinal compression fracture	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations C-reactive protein increased	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Neutrophil count decreased	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Platelet count decreased	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Dehydration	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Arthritis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Cerebral infarction	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Dizziness	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Subarachnoid haemorrhage	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Syncope	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Psychiatric disorders Delirium	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Psychiatric disorders Depression	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Renal and urinary disorders Urinary retention	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Reproductive system and breast disorders Prostatitis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Surgical and medical procedures Cataract operation	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Vascular disorders Circulatory collapse	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Vascular disorders Deep vein thrombosis	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants

Other adverse events

Measure	Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) n=40 participants at risk Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered: * 28 mg taken orally (3 - 24 hours prior to start of elotuzumab infusion) AND * 8 mg IV (at least 45 minutes prior to elotuzumab administration) On weeks when elotuzumab is NOT administered: \- 40 mg taken orally Elotuzumab (BMS-901608) * Cycle 1 - 2: 10 mg/kg IV, Days 1, 8, 15, 22 * Cycle 3 - 18: 10 mg/kg IV, Days 1 and 15 * Cycle 19 and beyond: 20 mg/kg IV, Day 1	Arm B: Lenalidomide + Dexamethasone n=42 participants at risk Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle
Nervous system disorders Headache	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Hypoaesthesia	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Dizziness	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	14.3% 6/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Dysgeusia	20.0% 8/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	21.4% 9/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Blood and lymphatic system disorders Anaemia	20.0% 8/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	14.3% 6/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Blood and lymphatic system disorders Leukopenia	22.5% 9/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Blood and lymphatic system disorders Lymphopenia	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Blood and lymphatic system disorders Neutropenia	27.5% 11/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	21.4% 9/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Cardiac disorders Atrial fibrillation	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Ear and labyrinth disorders Tinnitus	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Ear and labyrinth disorders Vertigo	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Eye disorders Cataract	42.5% 17/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	28.6% 12/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Eye disorders Dry eye	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Eye disorders Glaucoma	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Abdominal discomfort	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Abdominal pain upper	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Chronic gastritis	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Constipation	42.5% 17/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	31.0% 13/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Dental caries	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Diarrhoea	42.5% 17/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	28.6% 12/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Haemorrhoids	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Nausea	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	11.9% 5/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Periodontal disease	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Stomatitis	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Gastrointestinal disorders Vomiting	22.5% 9/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Malaise	25.0% 10/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Non-cardiac chest pain	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Oedema	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Oedema peripheral	30.0% 12/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	28.6% 12/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
General disorders Pyrexia	42.5% 17/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	11.9% 5/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Hepatobiliary disorders Hepatic function abnormal	20.0% 8/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Bronchitis	20.0% 8/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Cellulitis	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Conjunctivitis	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Cystitis	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Gastroenteritis	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Gingivitis	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Hepatitis B reactivation	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Herpes virus infection	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Herpes zoster	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Influenza	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Nasopharyngitis	45.0% 18/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	42.9% 18/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Oral herpes	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Osteomyelitis	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Periodontitis	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Pharyngitis	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Pneumonia	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	19.0% 8/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Upper respiratory tract infection	17.5% 7/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	11.9% 5/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Infections and infestations Urinary tract infection	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Contusion	22.5% 9/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Skin abrasion	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Spinal compression fracture	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Injury, poisoning and procedural complications Tooth fracture	2.5% 1/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Blood creatinine increased	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations C-reactive protein increased	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Creatinine renal clearance decreased	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Lymphocyte count decreased	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Neutrophil count decreased	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Platelet count decreased	12.5% 5/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations Weight decreased	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Investigations White blood cell count decreased	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Decreased appetite	17.5% 7/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Dehydration	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hyperglycaemia	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hypokalaemia	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hyponatraemia	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 8/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Back pain	27.5% 11/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	31.0% 13/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Muscle spasms	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	19.0% 8/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	9.5% 4/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Myalgia	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Musculoskeletal and connective tissue disorders Neck pain	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Nervous system disorders Neuropathy peripheral	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Psychiatric disorders Delirium	15.0% 6/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Psychiatric disorders Insomnia	25.0% 10/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	26.2% 11/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Renal and urinary disorders Chronic kidney disease	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Renal and urinary disorders Renal impairment	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Respiratory, thoracic and mediastinal disorders Epistaxis	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	0.00% 0/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Respiratory, thoracic and mediastinal disorders Hiccups	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	11.9% 5/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Dry skin	10.0% 4/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	2.4% 1/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Pruritus	22.5% 9/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	14.3% 6/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Purpura	7.5% 3/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	4.8% 2/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Rash	30.0% 12/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	40.5% 17/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants
Vascular disorders Hypertension	5.0% 2/40 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized participants	7.1% 3/42 • All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months). All randomized 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