Trial Outcomes & Findings for Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma (NCT NCT03934684)

NCT ID: NCT03934684

Last Updated: 2025-08-06

Results Overview

A TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s). TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 101 participants
• Primary outcome timeframe: From the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group)
• Results posted on: 2025-08-06

Participant Flow

A total of 101 participants were enrolled into this study at 15 centers in India. The analyses presented in this results summary are based on the primary completion data. The primary completion data cut-off was 23 March 2023. The study is ongoing.

Screening assessments were conducted within 28 days before enrollment into the study.

Participant milestones

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Overall Study STARTED	49	52
Overall Study COMPLETED	7	3
Overall Study NOT COMPLETED	42	49

Reasons for withdrawal

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Overall Study Participants continuing in study	11	4
Overall Study Discontinuation of carfilzomib	20	30
Overall Study Death	2	2
Overall Study Lost to Follow-up	2	5
Overall Study Withdrawal by Subject	7	8

Baseline Characteristics

Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.	Total n=101 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 8.2 • n=93 Participants	61.9 years STANDARD_DEVIATION 9.9 • n=4 Participants	59.6 years STANDARD_DEVIATION 9.3 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	32 Participants n=93 Participants	37 Participants n=4 Participants	69 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=93 Participants	52 Participants n=4 Participants	101 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	49 Participants n=93 Participants	52 Participants n=4 Participants	101 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group)

Population: Measured in the safety analysis set, which included all enrolled participants who received at least one dose of the investigational product(s).

A TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s). TEAEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03. Any clinically significant laboratory changes over time were recorded as TEAEs.

Outcome measures

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	46 Participants	43 Participants

PRIMARY outcome

Timeframe: From the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group)

Population: Measured in the safety analysis set, which included all enrolled participants who received at least one dose of the investigational product(s).

A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.

Outcome measures

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 Participants Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 Participants Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Number of Participants Who Experienced Serious TEAEs	12 Participants	19 Participants

Adverse Events

Carfilzomib, Lenalidomide and Dexamethasone (KRd)

Serious events: 12 serious events

Other events: 45 other events

Deaths: 2 deaths

Carfilzomib and Dexamethasone (Kd)

Serious events: 19 serious events

Other events: 41 other events

Deaths: 2 deaths

Serious adverse events

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 participants at risk Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 participants at risk Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute cardiac event	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 2/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiotoxicity	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Visual impairment	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Neutropenic colitis	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Amoebic dysentery	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 2/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia acinetobacter	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia viral	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 2/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute lung injury	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Measure	Carfilzomib, Lenalidomide and Dexamethasone (KRd) n=49 participants at risk Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.	Carfilzomib and Dexamethasone (Kd) n=52 participants at risk Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
Blood and lymphatic system disorders Anaemia	14.3% 7/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	34.6% 18/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	10.2% 5/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphopenia	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	14.3% 7/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	18.4% 9/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	23.1% 12/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	2.0% 1/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	16.3% 8/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	21.2% 11/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	6.1% 3/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Asthenia	10.2% 5/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	17.3% 9/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	6.1% 3/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	17.3% 9/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	16.3% 8/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	25.0% 13/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.7% 4/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	12.2% 6/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 2/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.4% 8/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	6.1% 3/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	7.7% 4/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.6% 5/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	9.6% 5/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	11.5% 6/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	8.2% 4/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	26.5% 13/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	40.4% 21/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.4% 8/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	4.1% 2/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.8% 3/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	6.1% 3/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	6.1% 3/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.9% 1/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	18.4% 9/49 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	15.4% 8/52 • For all-cause mortality reporting, from enrollment until the end of study, death date or cutoff date, whichever occurred earlier (median [min, max] time on study was 8.7 [0.1, 25.6] months). For serious and other adverse event reporting, from the first dose date of any study drug until the end of study or cutoff date, whichever occurred earlier (median [min, max] time on treatment was 43.14 [4.4, 73.4] weeks for the KRd group and 28.79 [0.3, 107.3] weeks for the Kd group) All-cause mortality is reported for all participants enrolled in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER